COPD
Conditions
Brief summary
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product as measured by increases in FEV1.
Detailed description
A single center, open label, single dose study to demonstrate the pharmacodynamic bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate or albuterol sulfate/ipratropium in adult patients with COPD.
Interventions
COMBINATION_PRODUCTAlbuterol Sulfate and Ipratropium Bromide
COMBINATION_PRODUCTAlbuterol Sulfate
Sponsors
Pneuma Respiratory, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent * Diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines characterized by progressive airflow limitation associated with abnormal inflammatory response of the lungs to noxious particles or gases primarily caused by cigarette smoking. * Have an established COPD clinical history, symptomatic with dyspnea, chronic cough, chronic sputum production or wheezing. At Visit 1, FEV1/FVC ratio must be less than 0.70 or at least 10% less than the FEV1/FVC ratio determined by the predicted normal value. FEV1 must be less than 70% of the predicted normal value and greater than 25% of the predicted normal value. * Must be using one or more inhaled bronchodilators for treatment of COPD at the time of Visit 1. * Current or former smokers, with a history of at least 10 pack-years of cigarette smoking. Number of pack-years = (number of cigarettes per day/20) X (number of years smoked). * Willing, and in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol.
Exclusion criteria
* Current diagnosis of other respiratory disorder(s) including, but not limited to: alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis; sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or pulmonary thromboembolic disease. Patients with concomitant COPD and asthma will be allowed to participate. * Diagnosis of non-respiratory disorder(s) that are currently affecting lung function, as determined by he principal investigator including, but not limited to: congestive heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia; lupus; rheumatoid arthritis; or liver cirrhosis. * Unable to abstain from protocol defined prohibited medications during the screening and testing period. * Unable to withhold short acting bronchodilators for 6 hours prior to spirometry testing at the study visit. * Unable to perform acceptable or repeatable spirometry or comply with other study procedures. * Known allergic reaction to albuterol sulfate or ipratropium bromide. * Diagnosis of cancer that is not presumed to be in remission or cured. * Active alcohol or drug abuse. * Pregnant or lactating women. Pregnancy confirmed by a positive hCG test. * Treatment with another investigational study drug in another clinical study within the last 30 days or five half-lives, whichever is longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint: Change in FEV1 | Just prior to dosing and twenty minutes post dosing | Change in FEV1 |
Countries
United States
Outcome results
None listed