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

Bronchial Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02624505
• Other study ID #: U-SS-M-AS312
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2019
• Source: Cipla Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• 90 mcg Reference Product
Drug: 90 mcg Reference Product
• 180 mcg Reference Product
Drug: 180 mcg of Reference Product
• 90 mcg Test Product
Drug: 90 mcg of Test Product
• Placebo
Placebo Product

Locations

Country	Name	City	State
United States	Colorado Allergy and Asthma Centers	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Cipla Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)		1 day