A Crossover Study in the Treatment of Patients With COPD

Dey Pharma

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Formoterol Fumurate inhalation solution 20 mcg; Drug: Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00462540

201-081

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD
• Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
• Meet lung function requirements

Exclusion criteria

• Diagnosis of Asthma
• Significant disease other than COPD
• Female pregnant or lactating or planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)