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Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

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ClinicalTrials.gov Identifier: NCT02624505
Recruitment Status : Unknown
Verified March 2016 by Cipla Ltd..
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Cipla Ltd.

Brief Summary:
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: 90 mcg Reference Product Drug: 180 mcg Reference Product Drug: 90 mcg Test Product Drug: Placebo Phase 3

Detailed Description:
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.
Study Start Date : December 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Product
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
Drug: Placebo
Placebo Product
Active Comparator: 90 mcg Reference Product
Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
Drug: 90 mcg Reference Product
Drug: 90 mcg Reference Product
Other Name: Albuterol
Active Comparator: 180 mcg Reference Product
Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
Drug: 180 mcg Reference Product
Drug: 180 mcg of Reference Product
Other Name: Albuetrol
Experimental: 90 mcg Test Product
Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols
Drug: 90 mcg Test Product
Drug: 90 mcg of Test Product
Other Name: Albuterol



Primary Outcome Measures :
  1. Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second) [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant female subjects (18-65 years of age)
  • Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
  • Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
  • Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
  • Written informed consent.

Exclusion Criteria:

  • Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
  • History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
  • History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
  • History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
  • Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
  • Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624505


Contacts
Contact: Gulam Kadiri 00912225756457 gulam.kadiri@cipla.com
Contact: Jeevan Yewale 00912225756569 jeevan.yewale@cipla.com

Locations
United States, Colorado
Colorado Allergy and Asthma Centers Recruiting
Denver, Colorado, United States, 80230
Contact: David Pearlman, MD    720-858-7510    ds.pearlman@coloradoallergy.com   
Sponsors and Collaborators
Cipla Ltd.
Investigators
Study Chair: Dhiraj Abhyankar Cipla Ltd.

Responsible Party: Cipla Ltd.
ClinicalTrials.gov Identifier: NCT02624505     History of Changes
Other Study ID Numbers: U-SS-M-AS312
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Undecided

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action