Asthma Clinical Trial
Official title:
A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy,
placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of
tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients
homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor
(ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be
randomised into the 16 week double-blind treatment period in which they receive either
tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily
administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily.
After the 16 week treatment period all patients will receive salmeterol MDI twice daily for
four weeks.
The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume
in the First Second (FEV1) measurements with an electronic peak flow meter throughout the
study. Daily data on asthma control and use of rescue medication are recorded using an
electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma
Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure
and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.
n/a
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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