<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239431</url>
  </required_header>
  <id_info>
    <org_study_id>CREC 2017.336</org_study_id>
    <nct_id>NCT03239431</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Clinical Characteristics, Comorbidities, Treatment Status and Exacerbations of Asthma Patients</brief_title>
  <official_title>A 3 Year Longitudinal Study of the Level of Asthma Control and Treatment of Asthma Patients in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study that aims to determine the current demographics, clinical&#xD;
      characteristics, comorbidities, treatment status and exacerbations of asthma patients.&#xD;
&#xD;
      The primary objective of this study is to determine the current demographics, clinical&#xD;
      characteristics, comorbidities, treatment status and exacerbations of asthma patients.&#xD;
&#xD;
      The secondary objectives include: (1) to review the current practices of symptom control&#xD;
      assessment, (2) to determine the choice of pharmacological regimen, rate of guideline&#xD;
      adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the&#xD;
      pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in&#xD;
      adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung&#xD;
      function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers&#xD;
      that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to&#xD;
      determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate&#xD;
      the impact of comorbidities on asthma control.&#xD;
&#xD;
      400 out-patient asthma patients are planned to be recruited and they will be followed up for&#xD;
      3 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asthma is a common respiratory disease worldwide and in Hong Kong. According to the&#xD;
      estimation by the Center for Disease Control and Prevention in 2015, 7.6% adults in the&#xD;
      United States have asthma. In Hong Kong, the prevalence of asthma was estimated to be 10.1%&#xD;
      among 13 to 14 years old children and 5.8% in randomly selected Chinese elderly aged more&#xD;
      than 70. With a rising trend of life expectancy in Hong Kong, the epidemiology of asthma in&#xD;
      adult and elderly population may change over time. In addition, elderly patients with asthma&#xD;
      may present with a different spectrum of clinical characteristics and pharmacological&#xD;
      response.&#xD;
&#xD;
      Asthmatic exacerbation is one of the untoward complications and hospitalization for&#xD;
      exacerbations requiring ICU care and mechanical ventilation are both predictors for&#xD;
      near-fatal asthma. After the acute attack, its unfavourable impact continues and can lead to&#xD;
      multiple sequelae. Exacerbation of asthma is associated with a more rapid decline in the&#xD;
      post-bronchodilator forced expiratory volume in 1 second and worse quality of life. Without&#xD;
      adjustment of medical treatment, they are prone to develop another episode of exacerbation&#xD;
      within a short period of time. In addition, individuals with uncontrolled asthma had higher&#xD;
      medical expenditures and decreased productivity, contributing to a greater economic burden&#xD;
      when compared with individuals without asthma. In contrary, patients with controlled asthma&#xD;
      had lower hospitalization rate, mortality rate and less lung function decline. Many risk&#xD;
      factors for exacerbation had been identified including upper airway diseases,&#xD;
      gastroesophageal reflux, poor inhaler technique, medication non-compliance. Many of these&#xD;
      factors are potentially reversible. A model of better asthma care may be established by&#xD;
      improving the understanding on these risk factors, leading to less exacerbation events.&#xD;
&#xD;
      Asthma is not simply an airway disease. Accumulating evidence showed its coexistence with&#xD;
      other upper airway and systemic diseases, both atopic and non-atopic. These comorbidities&#xD;
      independently or linked together to impose negative impact on patients' health status and&#xD;
      quality of life. Knowing about the burden of asthma related comorbidities may help to guide&#xD;
      clinician in managing these complications in a more effective way, and even prediction of&#xD;
      subsequent prognosis.&#xD;
&#xD;
      Since the launching of GINA guideline in year 1993, its regular evidence-based update on&#xD;
      pharmacological treatment had revolutionize the care of asthma patients. The use of asthma&#xD;
      medications by both specialists and primary care physicians became more structured and the&#xD;
      asthma control was improved. However, there is still a significant proportion of asthma&#xD;
      patients experiencing recurrent exacerbation despite optimization of pharmacological&#xD;
      treatment. Both the guideline adherence by physicians and drug compliance by patient are&#xD;
      subjects of concern.&#xD;
&#xD;
      Previous evidence showed that the compliance rate of GINA guideline is far from satisfactory,&#xD;
      which is a shared phenomenon among different common diseases even the presence of&#xD;
      well-established international guideline. Patient's drug compliance also contributes to&#xD;
      negative disease outcome, especially non-adherence to inhaled corticosteroid. Currently, a&#xD;
      comprehensive view on the treatment status in and level of asthma control in Hong Kong is&#xD;
      still lacking.&#xD;
&#xD;
      A large knowledge gap exists between the current demographics, comorbidities, treatment&#xD;
      status, level of asthma control and exacerbations in Hong Kong. An updated study on these&#xD;
      aspects is definitely warranted to enhance patient care and guide further research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>The clinical characteristics of asthma patients</measure>
    <time_frame>over 3 years</time_frame>
    <description>The clinical characteristics of asthma patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The treatment status of asthma patients</measure>
    <time_frame>over 3 years</time_frame>
    <description>The treatment status of asthma patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 3 year morbidity of asthma patients</measure>
    <time_frame>over 3 years</time_frame>
    <description>The 3 year morbidity of asthma patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 3 year mortality of asthma patients</measure>
    <time_frame>over 3 years</time_frame>
    <description>The 3 year mortality of asthma patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic markers that predict exacerbation</measure>
    <time_frame>over 3 years</time_frame>
    <description>Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Asthma group</arm_group_label>
    <description>Patients with asthma</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>asthmatic exacerbation</intervention_name>
    <description>evaluate the risk factors, frequency and nature of asthma exacerbations</description>
    <arm_group_label>Asthma group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Genetic markers in blood sample that can help to predict exacerbation and level of control in&#xD;
      patients with asthma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients are recruited from the medical out-patient clinic by the physicians in the Prince&#xD;
        of Wales Hospital. As the physicians will both attend general medical clinics and&#xD;
        respiratory clinics, they will recruit patients from these clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients with confirmed diagnosis of asthma (defined as those with a consistent&#xD;
             history and prior documented evidence of variable airflow obstruction, with evidence&#xD;
             of an increase in FEV1 greater than 12% or 200 mL following bronchodilator or&#xD;
             bronchial hyperresponsiveness on bronchial provocation testing, when stable&#xD;
             (reference)&#xD;
&#xD;
          2. Age greater than 18 years old&#xD;
&#xD;
          3. Signed written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients currently with acute exacerbation of asthma by GINA guideline (they can join&#xD;
             the study after 6 weeks post recovery from the exacerbation)&#xD;
&#xD;
          2. Patients with respiratory diseases that can show similar symptoms to asthma such as&#xD;
             bronchiectasis, tuberculosis-destroyed lung parenchyma, endobronchial TB, and lung&#xD;
             cancer, or those who have history of these diseases based on physician's judgment&#xD;
&#xD;
          3. Patients with respiratory diseases that may confound the lung function parameters such&#xD;
             as pleural diseases, interstitial lung diseases, and previous lung surgery, or those&#xD;
             who have history of these diseases based on physician's judgment&#xD;
&#xD;
          4. Patients with neuromuscular diseases that may affect the seal off the mouthpiece&#xD;
             during spirometry and forced oscillometry technique (FOT)&#xD;
&#xD;
          5. Patients with uncontrolled or active contagious respiratory infection diseases&#xD;
&#xD;
          6. Patients with smoking history more than 10 pack years&#xD;
&#xD;
          7. Significant comorbid illnesses that limit the life expectancy to less than 1 year&#xD;
&#xD;
          8. Patients who are mentally not fit or physically contraindicated for spirometry and FOT&#xD;
&#xD;
          9. Patients with psychiatric disease or cognitive impairment that may limit their ability&#xD;
             of understanding or giving consent to the study&#xD;
&#xD;
         10. Patients currently randomized in other clinical studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka Pang Chan, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ka Pang Chan, MBChB</last_name>
    <phone>852 3505 3396</phone>
    <email>chankapang@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fanny WS Ko, MBChB, MD</last_name>
    <phone>852 3505 3396</phone>
    <email>fannyko@cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ka Pang Chan, MBChB</last_name>
      <phone>852 3505 3396</phone>
      <email>chankapang@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Fanny WS Ko, MBChB, MD</last_name>
      <phone>852 3505 3396</phone>
      <email>fannyko@cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <link>
    <url>https://www.cdc.gov/asthma/most_recent_data.htm</url>
    <description>CDC information on asthma. Assessed on 28 April 2017</description>
  </link>
  <reference>
    <citation>Wong GW, Leung TF, Ko FW. Changing prevalence of allergic diseases in the Asia-pacific region. Allergy Asthma Immunol Res. 2013 Sep;5(5):251-7. doi: 10.4168/aair.2013.5.5.251. Epub 2013 Mar 18.</citation>
    <PMID>24003381</PMID>
  </reference>
  <reference>
    <citation>Ko FW, Lai CK, Woo J, Ho SC, Ho CW, Goggins W, Hui DS. 12-year change in prevalence of respiratory symptoms in elderly Chinese living in Hong Kong. Respir Med. 2006 Sep;100(9):1598-607. doi: 10.1016/j.rmed.2005.12.007. Epub 2006 Jan 30.</citation>
    <PMID>16446081</PMID>
  </reference>
  <reference>
    <citation>Pasha MA, Sundquist B, Townley R. Asthma pathogenesis, diagnosis, and management in the elderly. Allergy Asthma Proc. 2017 May 1;38(3):184-191. doi: 10.2500/aap.2017.38.4048.</citation>
    <PMID>28441988</PMID>
  </reference>
  <reference>
    <citation>Serrano-Pariente J, Plaza V. Near-fatal asthma: a heterogeneous clinical entity. Curr Opin Allergy Clin Immunol. 2017 Feb;17(1):28-35. doi: 10.1097/ACI.0000000000000333.</citation>
    <PMID>27870665</PMID>
  </reference>
  <reference>
    <citation>Turner MO, Noertjojo K, Vedal S, Bai T, Crump S, Fitzgerald JM. Risk factors for near-fatal asthma. A case-control study in hospitalized patients with asthma. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1804-9. doi: 10.1164/ajrccm.157.6.9708092.</citation>
    <PMID>9620909</PMID>
  </reference>
  <reference>
    <citation>Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.</citation>
    <PMID>17537763</PMID>
  </reference>
  <reference>
    <citation>O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31. Erratum In: Am J Respir Crit Care Med. 2010 Oct 1;182(7):983-4.</citation>
    <PMID>18990678</PMID>
  </reference>
  <reference>
    <citation>Luskin AT, Chipps BE, Rasouliyan L, Miller DP, Haselkorn T, Dorenbaum A. Impact of asthma exacerbations and asthma triggers on asthma-related quality of life in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):544-52.e1-2. doi: 10.1016/j.jaip.2014.02.011. Epub 2014 Jul 3.</citation>
    <PMID>25213047</PMID>
  </reference>
  <reference>
    <citation>Miller MK, Lee JH, Miller DP, Wenzel SE; TENOR Study Group. Recent asthma exacerbations: a key predictor of future exacerbations. Respir Med. 2007 Mar;101(3):481-9. doi: 10.1016/j.rmed.2006.07.005. Epub 2006 Aug 17.</citation>
    <PMID>16914299</PMID>
  </reference>
  <reference>
    <citation>Sullivan PW, Slejko JF, Ghushchyan VH, Sucher B, Globe DR, Lin SL, Globe G. The relationship between asthma, asthma control and economic outcomes in the United States. J Asthma. 2014 Sep;51(7):769-78. doi: 10.3109/02770903.2014.906607. Epub 2014 Apr 7.</citation>
    <PMID>24697738</PMID>
  </reference>
  <reference>
    <citation>Moorman JE, Akinbami LJ, Bailey CM, Zahran HS, King ME, Johnson CA, Liu X. National surveillance of asthma: United States, 2001-2010. Vital Health Stat 3. 2012 Nov;(35):1-58.</citation>
    <PMID>24252609</PMID>
  </reference>
  <reference>
    <citation>ten Brinke A, Sterk PJ, Masclee AA, Spinhoven P, Schmidt JT, Zwinderman AH, Rabe KF, Bel EH. Risk factors of frequent exacerbations in difficult-to-treat asthma. Eur Respir J. 2005 Nov;26(5):812-8. doi: 10.1183/09031936.05.00037905.</citation>
    <PMID>16264041</PMID>
  </reference>
  <reference>
    <citation>Engelkes M, Janssens HM, de Jongste JC, Sturkenboom MC, Verhamme KM. Medication adherence and the risk of severe asthma exacerbations: a systematic review. Eur Respir J. 2015 Feb;45(2):396-407. doi: 10.1183/09031936.00075614. Epub 2014 Oct 16.</citation>
    <PMID>25323234</PMID>
  </reference>
  <reference>
    <citation>Tay TR, Radhakrishna N, Hore-Lacy F, Smith C, Hoy R, Dabscheck E, Hew M. Comorbidities in difficult asthma are independent risk factors for frequent exacerbations, poor control and diminished quality of life. Respirology. 2016 Nov;21(8):1384-1390. doi: 10.1111/resp.12838. Epub 2016 Jul 1.</citation>
    <PMID>27363539</PMID>
  </reference>
  <reference>
    <citation>Boulet LP. Influence of comorbid conditions on asthma. Eur Respir J. 2009 Apr;33(4):897-906. doi: 10.1183/09031936.00121308.</citation>
    <PMID>19336592</PMID>
  </reference>
  <reference>
    <citation>Robinson DS, Campbell DA, Durham SR, Pfeffer J, Barnes PJ, Chung KF; Asthma and Allergy Research Group of the National Heart and Lung Institute. Systematic assessment of difficult-to-treat asthma. Eur Respir J. 2003 Sep;22(3):478-83. doi: 10.1183/09031936.03.00017003.</citation>
    <PMID>14516138</PMID>
  </reference>
  <reference>
    <citation>Heaney LG, Conway E, Kelly C, Johnston BT, English C, Stevenson M, Gamble J. Predictors of therapy resistant asthma: outcome of a systematic evaluation protocol. Thorax. 2003 Jul;58(7):561-6. doi: 10.1136/thorax.58.7.561.</citation>
    <PMID>12832665</PMID>
  </reference>
  <reference>
    <citation>Bousquet J, Clark TJ, Hurd S, Khaltaev N, Lenfant C, O'byrne P, Sheffer A. GINA guidelines on asthma and beyond. Allergy. 2007 Feb;62(2):102-12. doi: 10.1111/j.1398-9995.2006.01305.x.</citation>
    <PMID>17298416</PMID>
  </reference>
  <reference>
    <citation>Dexheimer JW, Borycki EM, Chiu KW, Johnson KB, Aronsky D. A systematic review of the implementation and impact of asthma protocols. BMC Med Inform Decis Mak. 2014 Sep 9;14:82. doi: 10.1186/1472-6947-14-82.</citation>
    <PMID>25204381</PMID>
  </reference>
  <reference>
    <citation>Guarnaccia S, Lombardi A, Gaffurini A, Chiarini M, Domenighini S, D'Agata E, Schumacher RF, Spiazzi R, Notarangelo LD. Application and implementation of the GINA asthma guidelines by specialist and primary care physicians: a longitudinal follow-up study on 264 children. Prim Care Respir J. 2007 Dec;16(6):357-62. doi: 10.3132/pcrj.2007.00077.</citation>
    <PMID>18038103</PMID>
  </reference>
  <reference>
    <citation>Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.</citation>
    <PMID>25441637</PMID>
  </reference>
  <reference>
    <citation>Koga T, Oshita Y, Kamimura T, Koga H, Aizawa H. Characterisation of patients with frequent exacerbation of asthma. Respir Med. 2006 Feb;100(2):273-8. doi: 10.1016/j.rmed.2005.05.017. Epub 2005 Jul 5.</citation>
    <PMID>15998585</PMID>
  </reference>
  <reference>
    <citation>Scribano PV, Lerer T, Kennedy D, Cloutier MM. Provider adherence to a clinical practice guideline for acute asthma in a pediatric emergency department. Acad Emerg Med. 2001 Dec;8(12):1147-52. doi: 10.1111/j.1553-2712.2001.tb01131.x.</citation>
    <PMID>11733292</PMID>
  </reference>
  <reference>
    <citation>Shiffman RN, Freudigman Md, Brandt CA, Liaw Y, Navedo DD. A guideline implementation system using handheld computers for office management of asthma: effects on adherence and patient outcomes. Pediatrics. 2000 Apr;105(4 Pt 1):767-73. doi: 10.1542/peds.105.4.767.</citation>
    <PMID>10742318</PMID>
  </reference>
  <reference>
    <citation>Nestor A, Calhoun AC, Dickson M, Kalik CA. Cross-sectional analysis of the relationship between national guideline recommended asthma drug therapy and emergency/hospital use within a managed care population. Ann Allergy Asthma Immunol. 1998 Oct;81(4):327-30. doi: 10.1016/S1081-1206(10)63124-9.</citation>
    <PMID>9809496</PMID>
  </reference>
  <reference>
    <citation>Williams LK, Peterson EL, Wells K, Ahmedani BK, Kumar R, Burchard EG, Chowdhry VK, Favro D, Lanfear DE, Pladevall M. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol. 2011 Dec;128(6):1185-1191.e2. doi: 10.1016/j.jaci.2011.09.011. Epub 2011 Oct 21.</citation>
    <PMID>22019090</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ka Pang Chan</investigator_full_name>
    <investigator_title>Honorary Clinical Tutor</investigator_title>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>lung function</keyword>
  <keyword>forced oscillometry technique</keyword>
  <keyword>exacerbation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>upon individual approach for metaanalysis or related study</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239431
org study id: CREC 2017.336
nct id: NCT03239431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective cohort study that aims to determine the current demographics, clinical
      characteristics, comorbidities, treatment status and exacerbations of asthma patients.

      The primary objective of this study is to determine the current demographics, clinical
      characteristics, comorbidities, treatment status and exacerbations of asthma patients.

      The secondary objectives include: (1) to review the current practices of symptom control
      assessment, (2) to determine the choice of pharmacological regimen, rate of guideline
      adherence and real-world clinical practice in managing asthma patients, (3) to evaluate the
      pattern of lung function parameters (spirometry and forced oscillometry technique [FOT]) in
      adult asthma patients, (4) to evaluate the effect of ageing on the trend of change in lung
      function parameters (spirometry and FOT) in adult asthma patients, (5) to identify biomarkers
      that help to categorize different asthma phenotypes and predict subsequent prognosis, (6) to
      determine the risk factors of uncontrolled asthma and asthma exacerbation, (7) to evaluate
      the impact of comorbidities on asthma control.

      400 out-patient asthma patients are planned to be recruited and they will be followed up for
      3 years.
Asthma is a common respiratory disease worldwide and in Hong Kong. According to the
      estimation by the Center for Disease Control and Prevention in 2015, 7.6% adults in the
      United States have asthma. In Hong Kong, the prevalence of asthma was estimated to be 10.1%
      among 13 to 14 years old children and 5.8% in randomly selected Chinese elderly aged more
      than 70. With a rising trend of life expectancy in Hong Kong, the epidemiology of asthma in
      adult and elderly population may change over time. In addition, elderly patients with asthma
      may present with a different spectrum of clinical characteristics and pharmacological
      response.

      Asthmatic exacerbation is one of the untoward complications and hospitalization for
      exacerbations requiring ICU care and mechanical ventilation are both predictors for
      near-fatal asthma. After the acute attack, its unfavourable impact continues and can lead to
      multiple sequelae. Exacerbation of asthma is associated with a more rapid decline in the
      post-bronchodilator forced expiratory volume in 1 second and worse quality of life. Without
      adjustment of medical treatment, they are prone to develop another episode of exacerbation
      within a short period of time. In addition, individuals with uncontrolled asthma had higher
      medical expenditures and decreased productivity, contributing to a greater economic burden
      when compared with individuals without asthma. In contrary, patients with controlled asthma
      had lower hospitalization rate, mortality rate and less lung function decline. Many risk
      factors for exacerbation had been identified including upper airway diseases,
      gastroesophageal reflux, poor inhaler technique, medication non-compliance. Many of these
      factors are potentially reversible. A model of better asthma care may be established by
      improving the understanding on these risk factors, leading to less exacerbation events.

      Asthma is not simply an airway disease. Accumulating evidence showed its coexistence with
      other upper airway and systemic diseases, both atopic and non-atopic. These comorbidities
      independently or linked together to impose negative impact on patients' health status and
      quality of life. Knowing about the burden of asthma related comorbidities may help to guide
      clinician in managing these complications in a more effective way, and even prediction of
      subsequent prognosis.

      Since the launching of GINA guideline in year 1993, its regular evidence-based update on
      pharmacological treatment had revolutionize the care of asthma patients. The use of asthma
      medications by both specialists and primary care physicians became more structured and the
      asthma control was improved. However, there is still a significant proportion of asthma
      patients experiencing recurrent exacerbation despite optimization of pharmacological
      treatment. Both the guideline adherence by physicians and drug compliance by patient are
      subjects of concern.

      Previous evidence showed that the compliance rate of GINA guideline is far from satisfactory,
      which is a shared phenomenon among different common diseases even the presence of
      well-established international guideline. Patient's drug compliance also contributes to
      negative disease outcome, especially non-adherence to inhaled corticosteroid. Currently, a
      comprehensive view on the treatment status in and level of asthma control in Hong Kong is
      still lacking.

      A large knowledge gap exists between the current demographics, comorbidities, treatment
      status, level of asthma control and exacerbations in Hong Kong. An updated study on these
      aspects is definitely warranted to enhance patient care and guide further research.
observational model: Cohort
time perspective: Prospective
measure: The clinical characteristics of asthma patients
time frame: over 3 years
description: The clinical characteristics of asthma patients
measure: The treatment status of asthma patients
time frame: over 3 years
description: The treatment status of asthma patients
measure: The 3 year morbidity of asthma patients
time frame: over 3 years
description: The 3 year morbidity of asthma patients
measure: The 3 year mortality of asthma patients
time frame: over 3 years
description: The 3 year mortality of asthma patients
measure: Genetic markers that predict exacerbation
time frame: over 3 years
description: Genetic markers in blood sample that can help to predict exacerbation and level of control in patients with asthma
arm group label: Asthma group
description: Patients with asthma
intervention type: Other
intervention name: asthmatic exacerbation
description: evaluate the risk factors, frequency and nature of asthma exacerbations
arm group label: Asthma group
Genetic markers in blood sample that can help to predict exacerbation and level of control in
      patients with asthma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ka Pang Chan, MBChB
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Ka Pang Chan, MBChB
phone: 852 3505 3396
email: chankapang@gmail.com
last name: Fanny WS Ko, MBChB, MD
phone: 852 3505 3396
email: fannyko@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
url: https://www.cdc.gov/asthma/most_recent_data.htm
description: CDC information on asthma. Assessed on 28 April 2017
citation: Wong GW, Leung TF, Ko FW. Changing prevalence of allergic diseases in the Asia-pacific region. Allergy Asthma Immunol Res. 2013 Sep;5(5):251-7. doi: 10.4168/aair.2013.5.5.251. Epub 2013 Mar 18.
PMID: 24003381
citation: Ko FW, Lai CK, Woo J, Ho SC, Ho CW, Goggins W, Hui DS. 12-year change in prevalence of respiratory symptoms in elderly Chinese living in Hong Kong. Respir Med. 2006 Sep;100(9):1598-607. doi: 10.1016/j.rmed.2005.12.007. Epub 2006 Jan 30.
PMID: 16446081
citation: Pasha MA, Sundquist B, Townley R. Asthma pathogenesis, diagnosis, and management in the elderly. Allergy Asthma Proc. 2017 May 1;38(3):184-191. doi: 10.2500/aap.2017.38.4048.
PMID: 28441988
citation: Serrano-Pariente J, Plaza V. Near-fatal asthma: a heterogeneous clinical entity. Curr Opin Allergy Clin Immunol. 2017 Feb;17(1):28-35. doi: 10.1097/ACI.0000000000000333.
PMID: 27870665
citation: Turner MO, Noertjojo K, Vedal S, Bai T, Crump S, Fitzgerald JM. Risk factors for near-fatal asthma. A case-control study in hospitalized patients with asthma. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1804-9. doi: 10.1164/ajrccm.157.6.9708092.
PMID: 9620909
citation: Bai TR, Vonk JM, Postma DS, Boezen HM. Severe exacerbations predict excess lung function decline in asthma. Eur Respir J. 2007 Sep;30(3):452-6. doi: 10.1183/09031936.00165106. Epub 2007 May 30.
PMID: 17537763
citation: O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. doi: 10.1164/rccm.200807-1126OC. Epub 2008 Oct 31. Erratum In: Am J Respir Crit Care Med. 2010 Oct 1;182(7):983-4.
PMID: 18990678
citation: Luskin AT, Chipps BE, Rasouliyan L, Miller DP, Haselkorn T, Dorenbaum A. Impact of asthma exacerbations and asthma triggers on asthma-related quality of life in patients with severe or difficult-to-treat asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):544-52.e1-2. doi: 10.1016/j.jaip.2014.02.011. Epub 2014 Jul 3.
PMID: 25213047
citation: Miller MK, Lee JH, Miller DP, Wenzel SE; TENOR Study Group. Recent asthma exacerbations: a key predictor of future exacerbations. Respir Med. 2007 Mar;101(3):481-9. doi: 10.1016/j.rmed.2006.07.005. Epub 2006 Aug 17.
PMID: 16914299
citation: Sullivan PW, Slejko JF, Ghushchyan VH, Sucher B, Globe DR, Lin SL, Globe G. The relationship between asthma, asthma control and economic outcomes in the United States. J Asthma. 2014 Sep;51(7):769-78. doi: 10.3109/02770903.2014.906607. Epub 2014 Apr 7.
PMID: 24697738
citation: Moorman JE, Akinbami LJ, Bailey CM, Zahran HS, King ME, Johnson CA, Liu X. National surveillance of asthma: United States, 2001-2010. Vital Health Stat 3. 2012 Nov;(35):1-58.
PMID: 24252609
citation: ten Brinke A, Sterk PJ, Masclee AA, Spinhoven P, Schmidt JT, Zwinderman AH, Rabe KF, Bel EH. Risk factors of frequent exacerbations in difficult-to-treat asthma. Eur Respir J. 2005 Nov;26(5):812-8. doi: 10.1183/09031936.05.00037905.
PMID: 16264041
citation: Engelkes M, Janssens HM, de Jongste JC, Sturkenboom MC, Verhamme KM. Medication adherence and the risk of severe asthma exacerbations: a systematic review. Eur Respir J. 2015 Feb;45(2):396-407. doi: 10.1183/09031936.00075614. Epub 2014 Oct 16.
PMID: 25323234
citation: Tay TR, Radhakrishna N, Hore-Lacy F, Smith C, Hoy R, Dabscheck E, Hew M. Comorbidities in difficult asthma are independent risk factors for frequent exacerbations, poor control and diminished quality of life. Respirology. 2016 Nov;21(8):1384-1390. doi: 10.1111/resp.12838. Epub 2016 Jul 1.
PMID: 27363539
citation: Boulet LP. Influence of comorbid conditions on asthma. Eur Respir J. 2009 Apr;33(4):897-906. doi: 10.1183/09031936.00121308.
PMID: 19336592
citation: Robinson DS, Campbell DA, Durham SR, Pfeffer J, Barnes PJ, Chung KF; Asthma and Allergy Research Group of the National Heart and Lung Institute. Systematic assessment of difficult-to-treat asthma. Eur Respir J. 2003 Sep;22(3):478-83. doi: 10.1183/09031936.03.00017003.
PMID: 14516138
citation: Heaney LG, Conway E, Kelly C, Johnston BT, English C, Stevenson M, Gamble J. Predictors of therapy resistant asthma: outcome of a systematic evaluation protocol. Thorax. 2003 Jul;58(7):561-6. doi: 10.1136/thorax.58.7.561.
PMID: 12832665
citation: Bousquet J, Clark TJ, Hurd S, Khaltaev N, Lenfant C, O'byrne P, Sheffer A. GINA guidelines on asthma and beyond. Allergy. 2007 Feb;62(2):102-12. doi: 10.1111/j.1398-9995.2006.01305.x.
PMID: 17298416
citation: Dexheimer JW, Borycki EM, Chiu KW, Johnson KB, Aronsky D. A systematic review of the implementation and impact of asthma protocols. BMC Med Inform Decis Mak. 2014 Sep 9;14:82. doi: 10.1186/1472-6947-14-82.
PMID: 25204381
citation: Guarnaccia S, Lombardi A, Gaffurini A, Chiarini M, Domenighini S, D'Agata E, Schumacher RF, Spiazzi R, Notarangelo LD. Application and implementation of the GINA asthma guidelines by specialist and primary care physicians: a longitudinal follow-up study on 264 children. Prim Care Respir J. 2007 Dec;16(6):357-62. doi: 10.3132/pcrj.2007.00077.
PMID: 18038103
citation: Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.
PMID: 25441637
citation: Koga T, Oshita Y, Kamimura T, Koga H, Aizawa H. Characterisation of patients with frequent exacerbation of asthma. Respir Med. 2006 Feb;100(2):273-8. doi: 10.1016/j.rmed.2005.05.017. Epub 2005 Jul 5.
PMID: 15998585
citation: Scribano PV, Lerer T, Kennedy D, Cloutier MM. Provider adherence to a clinical practice guideline for acute asthma in a pediatric emergency department. Acad Emerg Med. 2001 Dec;8(12):1147-52. doi: 10.1111/j.1553-2712.2001.tb01131.x.
PMID: 11733292
citation: Shiffman RN, Freudigman Md, Brandt CA, Liaw Y, Navedo DD. A guideline implementation system using handheld computers for office management of asthma: effects on adherence and patient outcomes. Pediatrics. 2000 Apr;105(4 Pt 1):767-73. doi: 10.1542/peds.105.4.767.
PMID: 10742318
citation: Nestor A, Calhoun AC, Dickson M, Kalik CA. Cross-sectional analysis of the relationship between national guideline recommended asthma drug therapy and emergency/hospital use within a managed care population. Ann Allergy Asthma Immunol. 1998 Oct;81(4):327-30. doi: 10.1016/S1081-1206(10)63124-9.
PMID: 9809496
citation: Williams LK, Peterson EL, Wells K, Ahmedani BK, Kumar R, Burchard EG, Chowdhry VK, Favro D, Lanfear DE, Pladevall M. Quantifying the proportion of severe asthma exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol. 2011 Dec;128(6):1185-1191.e2. doi: 10.1016/j.jaci.2011.09.011. Epub 2011 Oct 21.
PMID: 22019090
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Ka Pang Chan
investigator title: Honorary Clinical Tutor
mesh term: Asthma
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 6 months after publication
ipd access criteria: upon individual approach for metaanalysis or related study