Clinical trial NCT03480997: Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD
Official title: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Pneuma Respiratory, Inc
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Efficacy Endpoint: Change in FEV1
timeFrame: Just prior to dosing and twenty minutes post dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Hickory
country: United States
facility: Advanced Respiratory and Sleep Medicine, PLLC
state: North Carolina
Study officials:
affiliation: Advanced Respiratory and Sleep Medicine, PLLC
name: Tom Stern, MD
role: PRINCIPAL_INVESTIGATOR
References: