A 24-week clinical study to check the efficacy and safety of QVM149 with a free triple combination of salmeterol/fluticasone plus tiotropium in patients with uncontrolled asthma.
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2018/08/015281
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 71
1 Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity >= step 4 (GINA 2017).
2 Patients who have used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1.
3 Patients must be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score >= 1.5 at visits 101 and 201 (randomization visit).
4 Patients with history of at least one severe asthma exacerbation (see section 6.4.5) 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 for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan.
5 Pre-bronchodilator FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators prior to spirometry at both Visit 101 and Visit 201.
6 Patients who demonstrate an increase in FEV1 of >= 12% and 200 mL 15 to 30 minutes after administration of 400microgram salbutamol or 360 microgram albuterol through a spacer device at visit 101
1 Patients who have a smoking history of greater than 20 pack years.
2 Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
3 Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).
4 Patients who have ever required intubation for a severe asthma attack or exacerbation.
5 Patients treated with a LAMA for asthma within 3 months prior to Visit 1.
6 Patients who have had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.
7 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 Investigators medical judgment at risk participating in study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate noninferiority of either QVM149 high-dose or QVM149 medium dose to comparator salmeterol/fluticasone + tiotropium in terms of <br/ ><br>Asthma Quality of Life Questionnaire <br/ ><br>(AQLQ)Timepoint: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total <br/ ><br>score after 24 weeks of treatment
- Secondary Outcome Measures
Name Time Method ACQ is the Asthma Control Questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and the rescue medication use entered by the patient) validated to evaluate different levels of asthma controlTimepoint: Time Frame: Over 24 weeks;Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total scoreTimepoint: Time Frame: Over 24 weeks;Change from baseline in Forced Expiratory Flow between 25% and 75% of Forced Vital Capacity (FEF25-75)Timepoint: Time Frame: Over 24 weeks;Change from baseline in Forced Vital Capacity (FVC)Timepoint: Time Frame: Over 24 weeks;Percentage of patients achieving the minimal important difference (MCID) change from baseline ACQ-7 â?¥ 0.5 decreaseTimepoint: Time Frame: Over 24 weeks;Percentage of patients achieving the minimal important difference (MCID) change from baseline AQLQ â?¥ 0.5 increaseTimepoint: Time Frame: Over 24 weeks