NCT00742248

Formoterol Via pMDI HFA-134a Propellant or DPI in Partially Reversible Chronic Obstructive Pulmonary Disease (COPD)

Double Blind, Double Dummy, Multicentre, Randomised, Placebo- Controlled, Crossover Design Clinical Trial of 12 μg (Single Dose and Repeated Doses) Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant or DPI (Aerolizertm Inhaler) in Patients With Partially Reversible COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate equivalent efficacy between two different formulations of formoterol (pMDI using HFA-134 propellant and dry powder) on lung function in adult patients with partially reversible COPD.

Detailed description

The present study is aimed at investigating the effect of a single 12 µg dose and of a short 7-day course of formoterol HFA-134a, compared to a formoterol DPI formulation, on specific parameters that are appropriate for assessment of single-dose and short-term effects on COPD. This study has been designed to assess the efficacy with the traditional use of FEV1. Furthermore, the use of other efficacy parameters such as changes in exertion tolerance and dyspnoea, dynamic and static volumes measured using a whole body plethysmograph, such as TLC, RV, IC and airways conductance sGAW has been included. This is a double blind, double dummy, multicentre, randomised, placebo-controlled, cross-over study in at least 36 adult patients with partially reversible COPD. The two test treatments and placebo will be administered in a single and repeated (twice daily for 7 days) dose cycle (with a minimum 2 days and maximum 7 days of wash-out between each cycle). Seven clinic visits in total will take place at the start and end of the run-in period, and at the first and at the last dose of each treatment cycle (with placebo and the two active treatment tests), with an acceptable variation of a maximum of ± 1 day in respect of the scheduled days at the end of each treatment cycle (i.e. treatment with placebo or active drug may range between 6 and 8 days).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Formoterol	pMDI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
DRUG	Formoterol	DPI 12 mcg/dose 1 dose in the morning and 1 dose in the evening
DRUG	Placebo	Placebo pMDI/DPI 1 dose in the morning and 1 dose in the evening

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2008-08-27
• Last updated: 2020-07-31

Locations

1 site across 1 country: Italy