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.
Full Title of Study: “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”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 28, 2017
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.
- Combination Product: Albuterol Sulfate and Ipratropium Bromide
- Combination Product: Albuterol Sulfate
Arms, Groups and Cohorts
- Experimental: albuterol sulfate 100 mcg
- albuterol sulfate 100 mcg Test MDI
- Active Comparator: albuterol sulfate 200 mcg
- albuterol sulfate 200 mcg Reference MDI
- Experimental: albuterol sulfate and ipratropium bromide
- albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI
Clinical Trial Outcome Measures
- Primary Efficacy Endpoint: Change in FEV1
- Time Frame: Just prior to dosing and twenty minutes post dosing
- Change in FEV1
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Pneuma Respiratory, Inc
- Provider of Information About this Clinical Study
- Overall Official(s)
- Tom Stern, MD, Principal Investigator, Advanced Respiratory and Sleep Medicine, PLLC
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