Evaluation of the efficacy and safety of QMF149 vs Mometasone in patients with asthma

Phase 1

• Conditions: Asthma; MedDRA version: 18.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002529-21-LV
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Study Completion: 2019-06-28
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2216

Inclusion Criteria

1. Patients with a diagnosis of asthma, (GINA 2015 = step 3) for a period of at least 1 year prior to Visit 1
(Screening) 2. Patients who have used medium or high dose ICS (please refer to Appendix 11 for guidance) or low dose of LABA/ICS combinations for asthma for at least 1 year and at stable doses for at least 1 month prior to Visit 1
3. Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS and/or combinations of low dose ICS with longacting beta adrenergic agent. Patients must have ACQ-7 score = 1,5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS (GINA 2015 step= 3) 4. Pre-bronchodilator = 50% FEV1 of < 80% of the predicted normal value for the patient after withholding bronchodilators (see Table 5-2) at both Visit 101 and 102. • Withholding period of bronchodilators prior to spirometry: SABA for = 6 hours and FDC or free combinations of ICS*/LABA for = 48 hours, SAMA for = 8 hours, LAMA for = 7 days, theophylline o.d. for = 24 hours, theophylline b.i.d. for = 12 hours. • A onetime re-testing is allowed. 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. * ICS should be continued. 5. 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: - 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 - Reversibility may be repeated once
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 280
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

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) • 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 who have had a respiratory tract infection or asthma
worsening according to the definition in Section 6.4.6 within 4 weeks prior to
Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be rescreened
4 weeks after recovery from their respiratory tract infection or
asthma worsening. • 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified