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.

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2007-004608-11-FR
• Date of registration: 12/10/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public 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.
• Scientific 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.
• Date of first enrolment: 06/12/2007
• Target sample size: 28
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004608-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

asthma
MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Intervention(s)

Product Name: Indacaterol maleate / mometasone furoate
Product Code: QMF149
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Indacaterol maleate
Current Sponsor code: QAB149
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
INN or Proposed INN: Mometasone furoate
CAS Number: 83919-23-7
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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)

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.

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.

Secondary ID(s)

CQMF149A2203