<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/NCT03816267</url>
  </required_header>
  <id_info>
    <org_study_id>3244</org_study_id>
    <nct_id>NCT03816267</nct_id>
  </id_info>
  <brief_title>Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Asthma in Children</brief_title>
  <official_title>Effectiveness of Salbutamol Administration by Nebulizer Versus Metered Dose Inhaler With Spacer in Acute Asthma in Children in Suez Canal University Hospital Emergency Department: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suez Canal University</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>
      Asthma is a problem that affects many children and affects their physical health in addition&#xD;
      to having a social and financial burden on individuals, families and healthcare systems. In&#xD;
      our pediatric emergency department, nebulizers are still used for the management of asthma&#xD;
      and, with the poor resources of families, they have no option of treatment at home. In this&#xD;
      study, the investigators will compare the effectiveness of treatment through nebulizer versus&#xD;
      metered dose inhaler and spacer in children with an acute asthmatic attack seeking medical&#xD;
      care at the Pediatric Emergency Department of Suez Canal University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To determine whether the administration of a B2 agonist by metered dose inhaler with spacer&#xD;
      is as effective as the administration of B2 agonist by nebulizer for the treatment of an&#xD;
      acute asthmatic episode in children seeking medical care in the Pediatric Emergency&#xD;
      Department of Suez Canal University Hospital.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. Comparison of patients' visit duration in the ER room between the two groups.&#xD;
&#xD;
        2. Comparison of hospitalization rate between the two groups.&#xD;
&#xD;
        3. Comparison of parent/patient satisfaction between the two groups. Study design&#xD;
           Single-blinded randomized control trial.&#xD;
&#xD;
      Study location This study will be conducted in the Pediatric Emergency Department in Suez&#xD;
      Canal University Hospital.&#xD;
&#xD;
      Study population This study will include patients presenting with an acute exacerbation of&#xD;
      asthma at the Pediatric Emergency Department in Suez Canal University Hospital starting July&#xD;
      2017 until our sample size is fulfilled.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Children ranging from 2 - 14 years old. Both genders will be included. Patients with an acute&#xD;
      exacerbation of asthma.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      Patients with arrhythmia and cardiac diseases. Patients with thyroid diseases. Patients with&#xD;
      bronchiolitis, pneumonia. Patients with status asthmaticus requiring immediate pediatric&#xD;
      intensive care unit hospitalization.&#xD;
&#xD;
      Sampling All children fulfilling the inclusion criteria will be included consecutively until&#xD;
      the calculated sample size has been reached.&#xD;
&#xD;
      Sample size&#xD;
&#xD;
      The sample size will be calculated using the following formula:&#xD;
&#xD;
      (Dawson &amp; Trapp, 2004)&#xD;
&#xD;
      Where:&#xD;
&#xD;
      n= sample size Zα/2 = 1.96 (The critical value that divides the central 95% of the Z&#xD;
      distribution from the 5% in the tail) Zβ = 0.84 (The critical value that separates the lower&#xD;
      20% of the Z distribution from the upper 80%) σ = the estimate of the standard deviation =&#xD;
      1.5 (Rubilar et al., 2000) µ1 = mean in the nebulizer group = 4.4 (Rubilar et al., 2000) µ2 =&#xD;
      mean in the metered-dose inhaler group = 3.3 (Rubilar et al., 2000) So, by calculation, the&#xD;
      sample size will be equal to 30 cases per group, giving a total sample size of 60 cases.&#xD;
&#xD;
      Methods of data collection&#xD;
&#xD;
      Infants and children known to have asthma coming to the Pediatric Emergency Department of&#xD;
      Suez Canal University Hospital and fulfilling the inclusion criteria will be assessed&#xD;
      according to the following clinical respiratory score:&#xD;
&#xD;
      (Mild 0-3 moderate 4-7 severe 8-12)17&#xD;
&#xD;
      The target population is patients who presented with moderate to severe wheezing (score&#xD;
      4-12).&#xD;
&#xD;
      Randomization will take place through an online program for randomization of clinical trials.&#xD;
      The patients will be divided into two groups, one of them treated by the available nebulizer&#xD;
      and the other by MDI with spacer. The investigators cannot blind patients to the treatment as&#xD;
      there is an obvious difference between the two modalities.&#xD;
&#xD;
      However, the assessment of the respiratory score before and after the treatment will be&#xD;
      performed by an independent physician who will not be involved in the decision-making and&#xD;
      randomization of treatment. This physician will be asked to assess initially and then&#xD;
      reassess after the equipment has been removed to avoid any bias.&#xD;
&#xD;
      Dosage and administration:&#xD;
&#xD;
      The nebulizer group will receive salbutamol aerosol solution (0.25 mg/kg weight, up to a&#xD;
      maximum of 5 mg in 3.5 mL of normal saline solution. Aerosols will be generated by jet&#xD;
      nebulizers powered by oxygen and delivered via a face mask for 7 min every 20 min during the&#xD;
      first hour (a total of three nebulizations/hr.). A flow rate of 7 L/min will be used.&#xD;
&#xD;
      The metered dose inhaler with spacer group will receive two puffs of salbutamol (100&#xD;
      mcg/puff) every 10 min 5 times over 1 hr. (a total of 10 puffs/hr.), using a spacer device&#xD;
      with a face mask. Following each puff, the children will take breaths for a full minute from&#xD;
      the spacer device held in place.&#xD;
&#xD;
      Assessment:&#xD;
&#xD;
      Patients will be reassessed after one hour and score &lt;4 is considered a success while score&gt;4&#xD;
      is failure of therapy.&#xD;
&#xD;
      Patients of same degree of severity of the attack will be compared together according to the&#xD;
      following characteristics: duration of treatment preparation and delivery, clinical outcome,&#xD;
      patient satisfaction after use and hospitalization rate.&#xD;
&#xD;
      Each patient will have a form: Page 1 will be an informed consent to be signed before&#xD;
      randomization of treatment. Page 2 will include the following items&#xD;
&#xD;
        1. personal data (name, age, address, telephone number to be in contact with the patient&#xD;
           and know if there were repeated visits after this attack within the same week). In&#xD;
           addition, the researcher's phone number will be accessible to the patients.&#xD;
&#xD;
        2. Medical history (other illnesses, medications, degree of asthma either intermittent or&#xD;
           persistent)&#xD;
&#xD;
        3. Clinical assessment (clinical respiratory score before and after treatment)&#xD;
&#xD;
        4. Patient satisfaction with given modality on a Likert scale from 1-5. This will be asked&#xD;
           by the blinded assessor and will include questions regarding:&#xD;
&#xD;
             -  Comfort with modality used&#xD;
&#xD;
             -  Duration of modality used&#xD;
&#xD;
             -  Ease of administration&#xD;
&#xD;
             -  Confidence in repeating treatment on their own at home if required&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical improvement</measure>
    <time_frame>1 hour</time_frame>
    <description>Clinical respiratory score change (see Study Protocol for details)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Hospitalization</measure>
    <time_frame>4 hours</time_frame>
    <description>Admission into inpatient or intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 hour</time_frame>
    <description>Patient or parent satisfaction using Likert scale (see Study Protocol for details)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bronchial Asthma</condition>
  <arm_group>
    <arm_group_label>Nebulizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Containing salbutamol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metered Dose Inhaler and spacer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Containing Salbutamol</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nebulizer</intervention_name>
    <description>Nebulization via mask</description>
    <arm_group_label>Nebulizer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol</intervention_name>
    <description>Delivery of appropriate dose according to weight</description>
    <arm_group_label>Metered Dose Inhaler and spacer</arm_group_label>
    <arm_group_label>Nebulizer</arm_group_label>
    <other_name>Albuterol, Ventolin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Metered dose inhaler and spacer</intervention_name>
    <description>Medication will be delivered through inhaler and spacer</description>
    <arm_group_label>Metered Dose Inhaler and spacer</arm_group_label>
    <other_name>MDI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ranging from 2 - 14 years old.&#xD;
&#xD;
          -  Both genders will be included.&#xD;
&#xD;
          -  Patients with an acute exacerbation of asthma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with arrhythmia and cardiac diseases.&#xD;
&#xD;
          -  Patients with thyroid diseases.&#xD;
&#xD;
          -  Patients with bronchiolitis, pneumonia. Patients with status asthmaticus requiring&#xD;
             immediate pediatric intensive care unit hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa Zeitoun, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Suez Canal University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Suez Canal University Hospital</name>
      <address>
        <city>Ismailia</city>
        <zip>11411</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol. 2000 Apr;29(4):264-9. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-s.</citation>
    <PMID>10738013</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suez Canal University</investigator_affiliation>
    <investigator_full_name>Mona Azzam</investigator_full_name>
    <investigator_title>Lecturer of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03816267/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03816267
org study id: 3244
nct id: NCT03816267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Asthma is a problem that affects many children and affects their physical health in addition
      to having a social and financial burden on individuals, families and healthcare systems. In
      our pediatric emergency department, nebulizers are still used for the management of asthma
      and, with the poor resources of families, they have no option of treatment at home. In this
      study, the investigators will compare the effectiveness of treatment through nebulizer versus
      metered dose inhaler and spacer in children with an acute asthmatic attack seeking medical
      care at the Pediatric Emergency Department of Suez Canal University Hospital.
Primary Objective:

      To determine whether the administration of a B2 agonist by metered dose inhaler with spacer
      is as effective as the administration of B2 agonist by nebulizer for the treatment of an
      acute asthmatic episode in children seeking medical care in the Pediatric Emergency
      Department of Suez Canal University Hospital.

      Secondary Objectives:

        1. Comparison of patients' visit duration in the ER room between the two groups.

        2. Comparison of hospitalization rate between the two groups.

        3. Comparison of parent/patient satisfaction between the two groups. Study design
           Single-blinded randomized control trial.

      Study location This study will be conducted in the Pediatric Emergency Department in Suez
      Canal University Hospital.

      Study population This study will include patients presenting with an acute exacerbation of
      asthma at the Pediatric Emergency Department in Suez Canal University Hospital starting July
      2017 until our sample size is fulfilled.

      Inclusion criteria:

      Children ranging from 2 - 14 years old. Both genders will be included. Patients with an acute
      exacerbation of asthma.

      Exclusion criteria:

      Patients with arrhythmia and cardiac diseases. Patients with thyroid diseases. Patients with
      bronchiolitis, pneumonia. Patients with status asthmaticus requiring immediate pediatric
      intensive care unit hospitalization.

      Sampling All children fulfilling the inclusion criteria will be included consecutively until
      the calculated sample size has been reached.

      Sample size

      The sample size will be calculated using the following formula:

      (Dawson & Trapp, 2004)

      Where:

      n= sample size Zα/2 = 1.96 (The critical value that divides the central 95% of the Z
      distribution from the 5% in the tail) Zβ = 0.84 (The critical value that separates the lower
      20% of the Z distribution from the upper 80%) σ = the estimate of the standard deviation =
      1.5 (Rubilar et al., 2000) µ1 = mean in the nebulizer group = 4.4 (Rubilar et al., 2000) µ2 =
      mean in the metered-dose inhaler group = 3.3 (Rubilar et al., 2000) So, by calculation, the
      sample size will be equal to 30 cases per group, giving a total sample size of 60 cases.

      Methods of data collection

      Infants and children known to have asthma coming to the Pediatric Emergency Department of
      Suez Canal University Hospital and fulfilling the inclusion criteria will be assessed
      according to the following clinical respiratory score:

      (Mild 0-3 moderate 4-7 severe 8-12)17

      The target population is patients who presented with moderate to severe wheezing (score
      4-12).

      Randomization will take place through an online program for randomization of clinical trials.
      The patients will be divided into two groups, one of them treated by the available nebulizer
      and the other by MDI with spacer. The investigators cannot blind patients to the treatment as
      there is an obvious difference between the two modalities.

      However, the assessment of the respiratory score before and after the treatment will be
      performed by an independent physician who will not be involved in the decision-making and
      randomization of treatment. This physician will be asked to assess initially and then
      reassess after the equipment has been removed to avoid any bias.

      Dosage and administration:

      The nebulizer group will receive salbutamol aerosol solution (0.25 mg/kg weight, up to a
      maximum of 5 mg in 3.5 mL of normal saline solution. Aerosols will be generated by jet
      nebulizers powered by oxygen and delivered via a face mask for 7 min every 20 min during the
      first hour (a total of three nebulizations/hr.). A flow rate of 7 L/min will be used.

      The metered dose inhaler with spacer group will receive two puffs of salbutamol (100
      mcg/puff) every 10 min 5 times over 1 hr. (a total of 10 puffs/hr.), using a spacer device
      with a face mask. Following each puff, the children will take breaths for a full minute from
      the spacer device held in place.

      Assessment:

      Patients will be reassessed after one hour and score <4 is considered a success while score>4
      is failure of therapy.

      Patients of same degree of severity of the attack will be compared together according to the
      following characteristics: duration of treatment preparation and delivery, clinical outcome,
      patient satisfaction after use and hospitalization rate.

      Each patient will have a form: Page 1 will be an informed consent to be signed before
      randomization of treatment. Page 2 will include the following items

        1. personal data (name, age, address, telephone number to be in contact with the patient
           and know if there were repeated visits after this attack within the same week). In
           addition, the researcher's phone number will be accessible to the patients.

        2. Medical history (other illnesses, medications, degree of asthma either intermittent or
           persistent)

        3. Clinical assessment (clinical respiratory score before and after treatment)

        4. Patient satisfaction with given modality on a Likert scale from 1-5. This will be asked
           by the blinded assessor and will include questions regarding:

             -  Comfort with modality used

             -  Duration of modality used

             -  Ease of administration

             -  Confidence in repeating treatment on their own at home if required
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical improvement
time frame: 1 hour
description: Clinical respiratory score change (see Study Protocol for details)
measure: Rate of Hospitalization
time frame: 4 hours
description: Admission into inpatient or intensive care unit
measure: Patient satisfaction
time frame: 1 hour
description: Patient or parent satisfaction using Likert scale (see Study Protocol for details)
arm group label: Nebulizer
arm group type: Active Comparator
description: Containing salbutamol
arm group label: Metered Dose Inhaler and spacer
arm group type: Experimental
description: Containing Salbutamol
intervention type: Device
intervention name: Nebulizer
description: Nebulization via mask
arm group label: Nebulizer
intervention type: Drug
intervention name: Salbutamol
description: Delivery of appropriate dose according to weight
arm group label: Metered Dose Inhaler and spacer
arm group label: Nebulizer
other name: Albuterol, Ventolin
intervention type: Device
intervention name: Metered dose inhaler and spacer
description: Medication will be delivered through inhaler and spacer
arm group label: Metered Dose Inhaler and spacer
other name: MDI
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: No
last name: Alaa Zeitoun, Prof
role: Study Chair
affiliation: Suez Canal University
facility: 
country: Egypt
citation: Rubilar L, Castro-Rodriguez JA, Girardi G. Randomized trial of salbutamol via metered-dose inhaler with spacer versus nebulizer for acute wheezing in children less than 2 years of age. Pediatr Pulmonol. 2000 Apr;29(4):264-9. doi: 10.1002/(sici)1099-0496(200004)29:43.0.co;2-s.
PMID: 10738013
responsible party type: Principal Investigator
investigator affiliation: Suez Canal University
investigator full name: Mona Azzam
investigator title: Lecturer of Pediatrics
mesh term: Asthma
mesh term: Albuterol
sharing ipd: No
provided document: 