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

NCT03480997 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: 2016-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint: Change in FEV1

  Change in FEV1

  Just prior to dosing and twenty minutes post dosing

Study Arms (3)

albuterol sulfate 100 mcg

EXPERIMENTAL

albuterol sulfate 100 mcg Test MDI

Combination Product: Albuterol Sulfate

albuterol sulfate 200 mcg

ACTIVE COMPARATOR

albuterol sulfate 200 mcg Reference MDI

Combination Product: Albuterol Sulfate

albuterol sulfate and ipratropium bromide

EXPERIMENTAL

albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI

Combination Product: Albuterol Sulfate and Ipratropium Bromide

Interventions

Albuterol Sulfate and Ipratropium Bromide COMBINATION_PRODUCT

albuterol sulfate and ipratropium bromide

Albuterol Sulfate COMBINATION_PRODUCT

albuterol sulfate 100 mcg; albuterol sulfate 200 mcg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pneuma Respiratory, Inc: lead

Study Sites (1)

Advanced Respiratory and Sleep Medicine, PLLC

Hickory, North Carolina, 28601, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Ipratropium

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Tom Stern, MD

  Advanced Respiratory and Sleep Medicine, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: December 27, 2016
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (1)