A multicenter, randomized, 52-week, double-blind, parallelgroup, active controlled study to compare the efficacy and safety of QVM149 with QMF149 in patients with asthma
- Conditions
- chronic inflammatory disorder of the airwayshyperresponsiveness of the airways10010613
- Registration Number
- NL-OMON47663
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1. Male and female adult patient * 18 years old and * 75 years.
2. Written informed consent must be obtained before any study-related assessment is
performed.
3. Patients with a diagnosis of asthma, (GINA 2015 * step 4) for a period of at least 1 year
prior to Visit 1 (Screening).
4. Patients who have used medium or high dose ICS/LABA combinations (protocol Appendix 10) for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1.
5. Patients must be symptomatic at screening despite treatment with mid or high stable doses
of ICS/LABA. Patients with ACQ-7 score * 1.5 at Visit 101 and at Visit 102 (before randomization) (GINA 2015* step 4). In case that the spiromety is repeated. ACQ-7 should be repeaded as well.
6. 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.
Previous asthma exacerbation in this context is based on patient*s recall of unplanned need
for medical care at any primary care physician, pulmonologist, emergency room or hospital and treatment with systemic corticosteroids due to asthma exacerbation. Investigator must use appropriate means to ensure the accuracy of the patient's exacerbation history (e.g. Patient history at Visit 1 documentend in source notes, pharmacy recored, hospital records, or chart records are acceptable)
7. Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient according to ATS/ERS guidelines after withholding bronchodilators (protocol Table 5-2) at both visits 101 and 102.
8. Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes
after administration of 400 *g salbutamol/360 *g albuterol (or equivalent dose) at Visit 101.
1. Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years (Note:1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or * pack/day x 20 yrs.) This includes inhalers such as e-cigarettes at time of Visit 1.
2. 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.
3. Patients who have ever required intubation for a severe asthma attack/exacerbation.
4. 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.
5. Patients treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to demonstrate superiority of either<br /><br>QVM149 150/50/80 *g o.d. to QMF149 150/160 *g o.d. or QVM149 150/50/160 *g o.d.<br /><br>to QMF149 150/320 *g o.d. all delivered via Concept1 in terms of trough FEV1<br /><br>after 26 weeks of treatment in patients with asthma.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The key secondary objective is to demonstrate the superiority of either QVM149<br /><br>150/50/80 *g o.d. to QMF149 150/160 *g o.d. or QVM149 150/50/160 *g o.d. to<br /><br>QMF149 150/320 *g o.d., all delivered via Concept1, in terms of ACQ-7 after 26<br /><br>and 52 weeks of treatment in patients with asthma.</p><br>