A Single-Dose, Double Blind, Crossover Trial to Determinate the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, Atrovent® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02260011 Phase 2 COMPLETED

The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	COMPLETED
Enrolment	41
Start date	2000-10

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

• Ipratropium bromide HFA-134a inhalation aerosol
• Atrovent® CFC inhalation aerosol
• Placebo

Primary outcomes

• Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6) — After each drug administration