Phase 3
Completed N=802
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Source: ClinicalTrials.gov NCT02892344 ↗Enrolled (actual)
802
Serious AEs
1.5%
Results posted
Sep 2019
Primary outcomePrimary: Trough FEV1 — 2.562; 2.379 Liters — p=<0.001
◆ Published Evidence
Established
21citations · ~5 / year
Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis.
Summary
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
Linked Publications
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Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 |
2.562; 2.379 | <0.001 sig |
| SECONDARY ACQ-7 |
1.323; 1.540 | <0.001 sig |
| SECONDARY Trough FEV1 at Day 2 |
2.490; 2.358 | <0.001 sig |
| SECONDARY Pre-dose FEV1 at Week 4 |
2.545; 2.369 | <0.001 sig |
| SECONDARY FVC Over 12 Weeks |
3.453; 3.353; 2.030; 1.742 | <0.001 sig |
| SECONDARY PEF Over 4 and 12 Weeks |
31.0; 3.8; 26.8; 0.7 | <0.001 sig |
| SECONDARY Percentage of Patients With ACQ-7 MID at Week 12 |
74.7; 64.9 | — |
| SECONDARY Daily E-diary Over 12 Weeks |
13.4; 8.7; 14.7; 11.2; 17.1; 14.4 | — |
| SECONDARY ACQ-7 at Week 4 |
1.454; 1.658 | <0.001 sig |
| SECONDARY Rescue Medication Use Over 12 Weeks |
-0.26; -0.16; -0.39; -0.24 | <0.001 sig |
| SECONDARY Percentage of Rescue Medication Free Days Over 12 Weeks |
22.2; 14.1 | <0.001 sig |
| SECONDARY Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12 |
5.779; 5.630 | <0.001 sig |
| SECONDARY Number of Patients With Asthma Exacerbation Over 12 Weeks |
11; 29; 7; 23; 3; 11 | — |
| SECONDARY The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period |
0.08; 0.31; 0.20; 0.67 | — |
| SECONDARY Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period |
10; 32 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
- Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
- Adult patients who are symptomatic at screening despite treatment with existing therapy.
Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
- Adolescent patients :
- If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
- If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and 24 hours) or emergency room visit (≤ 24 hours) as follows:
- For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
- For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
- Patients who ever required intubation for a severe asthma attack/exacerbation
- Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
- Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
- 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 Type I diabetes or uncontrolled Type II diabetes.
- 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.
- Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
- Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.
Data sourced from ClinicalTrials.gov (NCT02892344) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.