A randomized, double-blind, placebo-controlled, parallel group study to investigate the safety and tolerability of 14-days treatment with an inhaled dose of QMF149 (500/800) in mild to moderate asthmatic patients.

ovartis Pharma Services AG0 sites28 target enrollmentOctober 12, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 12, 2007

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male and female adult patients aged 18\-65 years (inclusive), who have signed an Informed Consent Form prior to the initiation of any study\-related procedure
•2\. Patients with mild\-moderate asthma, diagnosed according to current GINA guidelines (National Institutes of Health. National Heart, Lung and Blood Institute, 2006\)
•3\. FEV1 at Visits 1 and 2 are \=60% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2\-agonist has been inhaled, and a minimum of 24 hours for a long acting ß2\-agonist.
•4\. BMI must be within the range of 18\-32\.
•5\. Except for asthma, subjects must be free of any clinically significant disease that might compromise patients' safety or compliance, would interfere with the study evaluations, or preclude completion of the trial.
•6\. Non\-smokers or light smokers (\=10 cigarettes per day), with a smoking history of 10 pack years or less.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•Subjects meeting any of the following criteria will be excluded from entry into or continuation in the study:
•1\. Patients who suffer from COPD (GOLD).
•2\. Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to Visit 1 or between Visit 1 and Visit 2\.
•3\. Patients who have had a respiratory tract infection within 1 month prior to Visit 1\. Patients who develop a respiratory tract infection during the screening period will be ineligible for randomisation, but will be permitted to re\-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
•4\. Patients with a QTc interval above 0\.45 msec for males and 0\.47 msec for females at the screening visit (Visit 1\).
•5\. Patients who have depression or with a history of treated depression within 6 months of screening.
•6\. Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
•7\. Patients must not be taking the following medications at entry into the study (Visit 2\); the washout period (prior to Visit 2\) for each of the relevant types of medications is specified below (Treatments for asthma and allied conditions):
•Asthma medication Washout period
•Fixed combinations of beta2\-agonists and inhaled corticosteroids 72 hours