Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Phase 3

• Conditions: Health Condition 1: null- Asthma

• Registration Number: CTRI/2016/06/007062
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Patients with a diagnosis of asthma, (GINA 2015 >= step 4) for a period of at least 1 year prior to Visit 1 (Screening).

•Patients who have used ICS/LABA combinations (Appendix 10) 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.

•Patients with ACQ-7 score >= 2 at Visit 1 (or 101 if no wash-out required) and at Visit 102 (randomization visit) (GINA 2015>= step 4).

•Patients with documented history of at least one asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment.

•Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient after withholding bronchodilators at both visits 101 and 102.

•Withholding period of bronchodilators prior to spirometry: SABA for >= 6 hrs, LABA (or FDC of ICS/LABA) for >= 24 hrs (48 hrs for indacaterol FDC), SAMA for >= 8 hrsxanthines >= 7 days.

•Retesting is allowed once only. Re-assessment of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Spacer devices are not permitted during reversibility testing.

•Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101.All patients must perform a reversibility test at Visit 101. If reversibility is not demonstrated at Visit 101 then one of the following criteria need to be met.

•Reversibility may be repeated once.

•Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 1 year prior to Visit 1.

•Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1. If reversibility is not demonstrated at Visit 101 (or after repeated assessment) and historical evidence of reversibility is not available (or was not performed according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines patients must be screen failed

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). If patients experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation.

•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, like glaucoma, cataract and fragility fractures, who are according to Investigator medical opinion 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 may be re-screened once their candidiasis has been treated and has resolved.

•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.

•Patients with diabetes Type I diabetes or uncontrolled Type II diabetes.

•Patients who, either in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition such as (but not limited to) unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.

•Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at the run-in (Visit 101) and end of run-in (Visit 102) visits with a resting ventri

Study & Design

• Study Type: Interventional
• Study Design: Not specified