xml: <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/NCT05986591</url>
    </required_header>
    <id_info>
      <org_study_id>2019-TIOT-0200-PD-01</org_study_id>
      <nct_id>NCT05986591</nct_id>
    </id_info>
    <brief_title>Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
    <acronym>ARBORUS</acronym>
    <official_title>A Multicenter, Randomized, Placebo-Controlled, Crossover, Single Dose Study To Demonstrate Clinical Pharmacodynamic Bioequivalence of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiromed LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Exeltis Healthcare S.L</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Laboratorios Liconsa SA</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Xiromed LLC</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pharmacodynamic bioequivalence study after a single dose of Tiotropium Bromide Inhalation&#xD;
        Powder 18 μg vs Spiriva Handihaler (Tiotropium Bromide) 18 mcg&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 17, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomized, placebo-controlled, single dose, three-way crossover design.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve</measure>
      <time_frame>24 Hours</time_frame>
      <description>Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">335</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment B: 18 mcg of Reference Product (Spiriva)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Test Product - Tiotropium Bromide Inhalation Powder 18 mcg</intervention_name>
      <description>Test Product</description>
      <arm_group_label>Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Spiriva Handihaler (Tiotropium Bromide) 18 mcg</intervention_name>
      <description>RLD</description>
      <arm_group_label>Treatment B: 18 mcg of Reference Product (Spiriva)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo Product</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)</arm_group_label>
      <arm_group_label>Treatment B: 18 mcg of Reference Product (Spiriva)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who have signed informed consent form before initiation of any study related&#xD;
               procedure.&#xD;
  &#xD;
            2. Male or non-pregnant female patients between 40 to 75 years of age at Screening Visit.&#xD;
  &#xD;
            3. General good health (except the COPD diagnosis) and free of any concomitant conditions&#xD;
               or treatment that could interfere with study conduct.&#xD;
  &#xD;
            4. An established physician diagnosis of COPD (GOLD 2022).&#xD;
  &#xD;
            5. Post-bronchodilator FEV1≤80% and ≥40% of predicted normal values (GLI-2012), and&#xD;
               post-bronchodilator FEV1/FVC ratio ≤0.70.&#xD;
  &#xD;
            6. Predose FEV1 values at Visits 4 and 5 within ± 20% of the Visit 3 FEV1.&#xD;
  &#xD;
            7. Able to replace their current short-acting bronchodilators with study-provided&#xD;
               albuterol/salbutamol inhalation aerosol provided at the Screening Visit (Visit 1) for&#xD;
               use as needed for the duration of the study.&#xD;
  &#xD;
            8. Patients must be able to discontinue their COPD maintenance medications during the&#xD;
               run-in and treatment periods.&#xD;
  &#xD;
            9. Patients must be able to withhold their short-acting β2-agonists for at least 6 hours&#xD;
               prior to spirometry on each clinic visit at the discretion of the investigator.&#xD;
  &#xD;
           10. Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack-Year= (cigarettes&#xD;
               smoked per day x years smoked)/20)).&#xD;
  &#xD;
           11. Not pregnant , breastfeeding, not a woman of childbearing potential (WOCBP) or WOCBP&#xD;
               using an acceptable contraceptive&#xD;
  &#xD;
           12. No occurrence of an upper or lower respiratory tract infection during the run-in&#xD;
               period.&#xD;
  &#xD;
           13. No COPD exacerbation, defined as any worsening of COPD requiring an emergency&#xD;
               department visit or hospitalization, or requiring excessive use of the&#xD;
               albuterol/salbutamol rescue medication during the run-in and/or treatment period at&#xD;
               the discretion of the Investigator, or the use of antibiotics and/or corticosteroids&#xD;
               during the run-in period and/or treatment period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Treatment for COPD exacerbation within 12 weeks prior to the Screening Visit or 2&#xD;
               or more exacerbations in the last year.&#xD;
  &#xD;
               2. Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit.&#xD;
  &#xD;
               3. History of a life-threatening COPD episode that required intubation and/or was&#xD;
               associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified&#xD;
               Medical Research Council) dyspnea Grade 4.&#xD;
  &#xD;
               4. Acute upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis,&#xD;
               urinary tract infection or illness within 8 weeks prior to the Screening Visit.&#xD;
  &#xD;
               5. Use of immediate-release (Oral or IV) corticosteroids within the last 30 days&#xD;
               and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks&#xD;
               prior to the Screening Visit 6. Patients with a history of asthma or a clinical&#xD;
               diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above&#xD;
               600/mm3.&#xD;
  &#xD;
               7. Patients with an abnormal/clinically significant 12-lead electrocardiogram (ECG)&#xD;
               prior to and during screening visit, during the run-in and treatment periods.&#xD;
  &#xD;
               8. Patients with myocardial infarction or unstable angina in the last 12 months;&#xD;
               unstable or life-threatening cardiac arrhythmia requiring intervention in the last 12&#xD;
               months; or New York Heart Association Class II-IV heart failure.&#xD;
  &#xD;
               9. Patients with documented pulmonary hypertension or clinical signs of right heart&#xD;
               failure (indicated by an increase in jugular venous pressure with or without&#xD;
               peripheral edema) or patients who require chronic oxygen use for &gt;12 hours per day.&#xD;
  &#xD;
               10. Presence of glaucoma or a history/family history of glaucoma. 11. History of&#xD;
               paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck&#xD;
               obstruction, or any other condition, which, in the opinion of the Investigator, would&#xD;
               contraindicate the use of an anticholinergic agent.&#xD;
  &#xD;
               12. Presence or history of urinary retention. 13. Historical or current evidence of a&#xD;
               clinically significant disease (Note: Significant is defined as any disease that, in&#xD;
               the opinion of the Investigator, would put the safety of the patient at risk through&#xD;
               participation, or which could affect the efficacy or safety analysis if the&#xD;
               disease/condition exacerbated during the study) including, but not limited to:&#xD;
  &#xD;
                 -  Cardiovascular (e.g., congestive heart failure, uncontrolled hypertension,&#xD;
                    uncontrolled coronary artery disease, stroke, or non-controlled arrhythmias),&#xD;
  &#xD;
                 -  Hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled&#xD;
                    diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, and&#xD;
                    Cushing's syndrome),&#xD;
  &#xD;
                 -  Gastrointestinal (e.g., poorly-controlled peptic ulcer disease),&#xD;
  &#xD;
                 -  Pulmonary disease other than COPD (e.g., alpha-1 antitrypsin deficiency, active&#xD;
                    bronchiectasis, cystic fibrosis, broncho-pulmonary dysplasia, sarcoidosis, lung&#xD;
                    fibrosis, pulmonary edema, interstitial lung disease, lung or mediastinum&#xD;
                    proliferative process including malignancies).&#xD;
  &#xD;
                    14. Patients who have undergone thoracotomy with pulmonary resection, have plans&#xD;
                    to undergo lung transplantation or lung volume reduction therapy, or have had&#xD;
                    lung volume reduction surgery within 12 months prior to the Screening Visit.&#xD;
  &#xD;
                    15. Have any of the following conditions that, in the judgment of the&#xD;
                    Investigator, might cause participation in this study to be detrimental to the&#xD;
                    patient, including but not limited to:&#xD;
  &#xD;
                 -  Current malignancy excluding basal cell carcinoma. (Note: History of malignancy&#xD;
                    is acceptable only if the patient has been in remission for one year prior to the&#xD;
                    Screening Visit. Remission is defined as no current evidence of malignancy and no&#xD;
                    treatment for the malignancy in the 5 years prior to the Screening Visit.&#xD;
  &#xD;
                 -  Current or untreated tuberculosis (Note: History of tuberculosis is acceptable&#xD;
                    only if a patient has received an approved prophylactic treatment regimen or an&#xD;
                    approved active treatment regimen and has had no evidence of active disease for a&#xD;
                    minimum of 2 years).&#xD;
  &#xD;
                 -  Uncontrolled hypertension (systolic blood pressure [BP] ≥160 or diastolic BP&#xD;
                    &gt;100).&#xD;
  &#xD;
                 -  Stroke within 12 months prior to the Screening Visit&#xD;
  &#xD;
                 -  Immunocompromised 17. History of allergy or hypersensitivity to&#xD;
                    anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic&#xD;
                    agonists, lactose/milk proteins, or specific intolerance to aerosolized&#xD;
                    tiotropium-containing products or its derivatives (e.g., ipratropium,&#xD;
                    oxitropium), or known hypersensitivity to any of the proposed ingredients or&#xD;
                    components of the delivery system.&#xD;
  &#xD;
                    18. History of alcohol or drug abuse within 2 years prior to the Screening Visit&#xD;
                    (Visit 1).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>DownTown LA Research (West Coast)</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90017</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Southwest General Heathcare</name>
        <address>
          <city>Fort Myers</city>
          <state>Florida</state>
          <zip>33907</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>SIMED Health</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32607</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clinical Research Solutions</name>
        <address>
          <city>Kissimmee</city>
          <state>Florida</state>
          <zip>34744</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clintex Research Group, Inc.</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33145</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Institue of South Florida</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33173</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Vista Health Research</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33176</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research - New Smyrna Beach</name>
        <address>
          <city>New Smyrna Beach</city>
          <state>Florida</state>
          <zip>32132</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Southern Clinical Research</name>
        <address>
          <city>Zachary</city>
          <state>Louisiana</state>
          <zip>70791</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity clinical Research Syracuse (East North))</name>
        <address>
          <city>Syracuse</city>
          <state>New York</state>
          <zip>13057</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research-Cincinnati</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45242</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Grants Pass (W Coast)</name>
        <address>
          <city>Grants Pass</city>
          <state>Oregon</state>
          <zip>97527</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Medford</name>
        <address>
          <city>Medford</city>
          <state>Oregon</state>
          <zip>97504</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Greater Providence Clinical Research (East North)</name>
        <address>
          <city>Cranston</city>
          <state>Rhode Island</state>
          <zip>02920</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Anderson</name>
        <address>
          <city>Anderson</city>
          <state>South Carolina</state>
          <zip>29621</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Columbia</name>
        <address>
          <city>Columbia</city>
          <state>South Carolina</state>
          <zip>29204</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Gaffney</name>
        <address>
          <city>Gaffney</city>
          <state>South Carolina</state>
          <zip>29340</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Greenville</name>
        <address>
          <city>Greenville</city>
          <state>South Carolina</state>
          <zip>29615</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Spartanburg</name>
        <address>
          <city>Spartanburg</city>
          <state>South Carolina</state>
          <zip>29303</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research Union</name>
        <address>
          <city>Union</city>
          <state>South Carolina</state>
          <zip>29379</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Inquest Clinical Research</name>
        <address>
          <city>Cypress</city>
          <state>Texas</state>
          <zip>77433</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Mt. Olympus Medical Research</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77479</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sante Clinical Research</name>
        <address>
          <city>Kerrville</city>
          <state>Texas</state>
          <zip>78028</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Velocity Clinical Research-Utah</name>
        <address>
          <city>West Jordan</city>
          <state>Utah</state>
          <zip>84088</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Anand Surgical Hospital Pvt. Ltd</name>
        <address>
          <city>Ahmedabad</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Care and Cure Multispeciality Hospital</name>
        <address>
          <city>Ahmedabad</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hope Medicare Centre</name>
        <address>
          <city>Ahmedabad</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Divine Multispeciality Hopsital</name>
        <address>
          <city>Gandhinagar</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Maharaja Agrasen Superspeciality Hospital</name>
        <address>
          <city>Jaipur</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shree Hospital &amp; Critical Care Centre</name>
        <address>
          <city>Nagpur</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chest Disease Hospital</name>
        <address>
          <city>Srinagar</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Global Hospital</name>
        <address>
          <city>Surat</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dhawal Multispeciality Hospital</name>
        <address>
          <city>Vadodara</city>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
      <mesh_term>Respiratory Aspiration</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bromides</mesh_term>
      <mesh_term>Tiotropium Bromide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986591
  org study id: 2019-TIOT-0200-PD-01
  nct id: NCT05986591
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg
  Pharmacodynamic bioequivalence study after a single dose of Tiotropium Bromide Inhalation
        Powder 18 μg vs Spiriva Handihaler (Tiotropium Bromide) 18 mcg
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized, placebo-controlled, single dose, three-way crossover design.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve
  time frame: 24 Hours
  description: Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment
  arm group label: Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)
  arm group type: Experimental
  arm group label: Treatment B: 18 mcg of Reference Product (Spiriva)
  arm group type: Active Comparator
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Combination Product
  intervention name: Test Product - Tiotropium Bromide Inhalation Powder 18 mcg
  description: Test Product
  arm group label: Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)
  intervention type: Combination Product
  intervention name: Spiriva Handihaler (Tiotropium Bromide) 18 mcg
  description: RLD
  arm group label: Treatment B: 18 mcg of Reference Product (Spiriva)
  intervention type: Combination Product
  intervention name: Placebo
  description: Placebo Product
  arm group label: Placebo
  arm group label: Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)
  arm group label: Treatment B: 18 mcg of Reference Product (Spiriva)
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
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  country: India
  country: United States
  responsible party type: Sponsor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Respiratory Aspiration
  mesh term: Bromides
  mesh term: Tiotropium Bromide
  sharing ipd: Undecided