Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single Center Study to Measure the Bronchodilator Effect of Albuterol Sulfate or Albuterol Sulfate/Ipratropium Bromide Using the Pneuma Respiratory Inhaler and the ProAir HFA Inhaler in Stable COPD Patients

Conditions
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COPD

Intervention / Treatment
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* Combination Product: Albuterol Sulfate and Ipratropium Bromide
* Combination Product: Albuterol Sulfate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albuterol sulfate 100 mcg<br>albuterol sulfate 100 mcg Test MDI | Combination Product: Albuterol Sulfate<br> <br> |
| Active Comparator: albuterol sulfate 200 mcg<br>albuterol sulfate 200 mcg Reference MDI | Combination Product: Albuterol Sulfate<br> <br> |
| Experimental: albuterol sulfate and ipratropium bromide<br>albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI | Combination Product: Albuterol Sulfate and Ipratropium Bromide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: Change in FEV1 | Change in FEV1 | Just prior to dosing and twenty minutes post dosing |