Official Title: “An Exploratory, Multi-Centre, Double-Blind, Placebo Controlled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler) in Adult Patients With Persistent Asthma Using Open Label Salmeterol/Fluticasone(50/250 Mcg b.i.d.) as an Active Control”

This study is designed to evaluate the bronchodilatory efficacy of QMF149 via a MDDPI device in adult patients with persistent asthma.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: QMF149 + matched placebo followed by an open label arm of fluticasone/salmeterol
• Drug: matched placebo + QMF149 followed by an open label arm of fluticasone/salmeterol

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • QMF149 + matched placebo followed by an open label arm of fluticasone/salmeterol
• Active Comparator: 2
  • matched placebo +QMF149 followed by an open label arm of fluticasone/salmeterol

Primary Measures

• Trough forced expiratory volume in one second (FEV1) change from baseline
  • Time Frame: throughout the study
    

Secondary Measures

• Peak forced expiratory volume in one second (FEV1) change from baseline
  • Time Frame: throughout the study
    
• FEV1, forced vital capacity (FVC) and FEV1/FVC ratio
  • Time Frame: throughout the study
    
• Pharmacokinetics
  • Time Frame: throughout the study
    

Inclusion Criteria:

• Male and female adult patients aged 18-75 years with persistent asthma
• BMI between18 and 32 and weight >50 kg
• Subjects using local contraception

Exclusion Criteria:

• Pregnant or nursing women
• Recent use of tobacco or history of heavy smoking
• Patients diagnosed with COPD
• Patients with recent experience of severe asthma attack/exacerbation
• Patients with frequent rescue medication
• Clinically relevant laboratory abnormality or a clinically significant condition
• Active cancer or a history of cancer with less than 5 years disease free survival time
• History of long QT syndrome or with long QTc interval prior to dosing
• History of hypersensitivity to the study drugs or to drugs with similar chemical structures
• Patients who have had live attenuated vaccinations within 30 days
• Use of certain medications
• Use of other investigational drugs
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
• History of immunodeficiency diseases, including a positive HIV test result.
• History of drug or alcohol abuse or evidence of such abuse
• Donation or loss of 400 ml or more of blood
• In custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitary or social institution.
• Any staff directly involved in the conduct of the protocol
• 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: 75 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 August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556673

Study ID Number: CQMF149A2204

ClinicalTrials.gov Identifier: NCT00556673

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