Mild Asthma
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit. * Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist) at stable dose for at least 1 month prior to Screening Visit. * Adult patients who are symptomatic at screening despite treatment with existing therapy. * Patients with ACQ-7 score >= 1.5 at Visit 101 and at Visit 102 (inadequately controlled). * Pre-bronchodilator FEV1 >= 60% 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 smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year. * Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (=< 24 hours) as follows: * For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation. * Patients who ever required intubation for a severe asthma attack/exacerbation. * Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment). * Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening. * Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study. * 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 Type I diabetes or uncontrolled Type II diabetes. * 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. * Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products. Other protocol defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy trough FEV1 [ Time Frame: 12 weeks ] demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. 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 by spirometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy ACQ-7 [ Time Frame: week 12 ] ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. efficacy trough FEV1 at day 2 [ Time Frame: week 12 ] 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. efficacy Pre-dose FEV1 at week 4 [ Time Frame: week 12 ] Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose. | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed