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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Combination product: Albuterol Sulfate; Combination product: Albuterol Sulfate and Ipratropium Bromide

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Advanced Respiratory and Sleep Medicine, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: albuterol sulfate 100 mcg; albuterol sulfate 100 mcg Test MDI	Combination product: Albuterol Sulfate
Active Comparator: albuterol sulfate 200 mcg; albuterol sulfate 200 mcg Reference MDI	Combination product: Albuterol Sulfate
Experimental: albuterol sulfate and ipratropium bromide; albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI	Combination product: Albuterol Sulfate and Ipratropium Bromide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pneuma Respiratory, Inc
• Investigators: Principal Investigator: Tom Stern, MD, Advanced Respiratory and Sleep Medicine, PLLC

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: 2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No