Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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
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.
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).
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