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

NCT03480997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-03-29

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Albuterol Sulfate and Ipratropium Bromide

COMBINATION_PRODUCT

Albuterol Sulfate

Sponsors & Collaborators

  • Pneuma Respiratory, Inc

    lead INDUSTRY

Principal Investigators

  • Tom Stern, MD · Advanced Respiratory and Sleep Medicine, PLLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-27
Primary Completion
2017-04-28
Completion
2017-04-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03480997 on ClinicalTrials.gov