asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Indacaterol maleate / mometasone furoate
Product Code: QMF149
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Indacaterol maleate
Current Sponsor code: QAB149
Concentration
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 Long acting beta2-agonists 24 hours Inhaled corticosteroids (ICS) 72 hours Parenteral and oral corticosteroids 3 months Theophylline and other xanthines 1 month Leukotriene antagonists 48 hours Anti-cholinergics: short acting 8 hours long acting 7 days Prohibited medication Washout period Non-potassium sparing diuretics 30 days Beta-blocking agents 30 days Quinidine-like medications 30 days Tri-cyclic antidepressants, fluoxetine or any other specific serotonin uptake receptor inhibitor, monoamino-oxidase inhibitors 30 days Desensitization therapy 30 days Terfenadine, astemizole, mizolastin and other drugs contra-indicated for QT prolongation 30 days Use of other investigational drugs 30 days or 5 half-lives of enrollment, whichever is longer 8. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures 9. Pregnant women or nursing mothers 10. 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). 11. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result. 12. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. 13. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of 14 days of once a day, evening treatment with QMF149 (500/800 using the Twisthaler®) in patients with mild to moderate asthma, with the aim of identifying unexpected, emergent toxicities resulting from combination of indacaterol and mometasone furoate.;Secondary Objective: To support evaluation of the performance and properties of available language translations of two new PRO (patient-reported outcomes) measures: the CASIS (COPD and Asthma Sleep Impact Scale) and the CAFS (COPD and Asthma Fatigue Scale);Primary end point(s): Safety and tolerability, as measured by (serious) adverse event monitoring, vital signs, digitally recorded ECG, hematology, blood chemistry, including serum plasma and cortisol and plasma glucose, FEV1, FVC, FEF25-75%, waking PEF for home monitoring. | — |
Countries
France
Outcome results
None listed