Official Title: “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”

This study will investigate the safety and tolerability of QMF149 after 14 days treatment in patients with mild to moderate asthma.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: QMF149
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Forced expiratory volume in 1 second (FEV1) on Days 1 and 14
  • Time Frame: throughout the study
    

Secondary Measures

• Level of potassium, glucose and cortisol in blood
  • Time Frame: throughout the study
    
• Quality of life assessed by CASIS (COPD [chronic obstructive pulmonary disease] and Asthma Sleep Impact Scale) and CAFS (COPD and Asthma Fatigue Scale) at baseline and Day 14
  • Time Frame: throughout the study
    

Inclusion Criteria:

• Male and female adult patients aged 18-65 years (inclusive)
• Patients with mild-moderate asthma
• FEV1 at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
• Body mass index (BMI) must be within the range of 18-32.
• Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.

Exclusion Criteria:

• Patients who suffer from COPD
• Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
• Pregnant women or nursing mothers
• Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
• History of immunocompromise, including a positive HIV
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• History of drug or alcohol abuse within 12 months of study start
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

NOVARTIS Principal Investigator Novartis investigator site  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00605306

Study ID Number: CQMF149A2203

ClinicalTrials.gov Identifier: NCT00605306

Health Authority: France: Afssaps - French Health Products Safety Agency