Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
- Conditions
- Asthma
- Registration Number
- JPRN-jRCT2080223228
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
* Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening).
* Patients who have used ICS/LABA combinations for asthma for at least 1 year and at stable medium or high doses of ICS/LABA 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/LABA.
* Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient after withholding bronchodilators at both visits 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.
* 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 treated with a LAMA for asthma within 12 months prior Visit 1 (Screening).
* Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered).
* Patients who have had a respiratory tract infection or asthma worsening according to the 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 evidence upon visual inspection (laboratory culture is not required) of clinically significant (in the opinion of investigator) oropharyngeal candidiasis at Visit 102 or earlier, with or without treatment.
* Patients with any chronic conditions affecting the upper respiratory tract (e.g. chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
* Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>trough FEV1 [ Time Frame: 26 weeks ]<br>To demonstrate superiority of either QVM149 150/50/80 microgram o.d. to QMF149 150/160 microgram o.d. or QVM149 150/50/160 microgram o.d. to QMF149 150/320 microgram o.d on through FEV1 over 26 weeks of treatment.<br>Forced Expiratory cvolume 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 Outcome Measures
Name Time Method safety<br>efficacy<br>Through FEV1 at week 52 [ Time Frame: week 52 ]<br>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.<br>safety<br>efficacy<br>FVC at week 4 and week 12 [ Time Frame: 12 weeks ]<br>FVC is the total amount of air exhaled during the FEV test.<br>safety<br>efficacy<br>PEF over 26 and 52 weeks [ Time Frame: 52 weeks ]<br>Measured in the morning and evening. PEF is the peak expiratory flow, the maximum speed of expiration.