Asthma
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening). * Patients who have used medium or high dose ICS or low dose of LABA/ICS combinations for asthma for at least 1 year and at stable doses for at least 1 month prior to Visit 1. * Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS and/or combinations of low dose ICS with long-acting beta adrenergic agent. * Pre-bronchodilator >= 50% FEV1 of < 80 % of the predicted normal value for the patient after withholding bronchodilators at both Visit 101 and 102. * Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
Exclusion criteria
Exclusion criteria: * Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). * Patients who have ever required intubation for a severe asthma attack/exacerbation. * Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study). * Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. * Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis. * Patients with narcolepsy and/or insomnia. * Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study. Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy trough FEV1 [ Time Frame: 26 weeks ] demonstrate the superiority of either QMF149 150/160 microgram delivered via Concept1 o.d. (in the evening) to MF 400 microgram o.d (in the evening) delivered via Twisthaler or QMF149 150/320 microgram delivered via Concept1 o.d. (in the evening) to MF 800 microgram delivered via Twisthaler (delivered as 400 microgram b.i.d.) Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Through FEV1 at week 52 [ Time Frame: week 52 ] Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing safety efficacy pre-dose FEV1 at week 4 and week 12 [ Time Frame: 12 weeks ] Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing safety efficacy FEV1 over 52 weeks [ Time Frame: 52 weeks ] Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed