Phase 2
Completed N=116
Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.
Source: ClinicalTrials.gov NCT03063086 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period — 2.792; 2.779; 2.620 Liters — p=<0.0001
Summary
The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period |
2.792; 2.779; 2.620 | <0.0001 sig |
| SECONDARY FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose |
2.6237; 2.5639; 2.4931; 2.6023; 2.5630; 2.4835 | — |
| SECONDARY FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose |
3.9046; 3.8538; 3.7626; 3.8743; 3.8571; 3.7230 | — |
| SECONDARY FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose |
0.6701; 0.6612; 0.6527; 0.6707; 0.6669; 0.6539 | — |
| SECONDARY FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21) |
2.673; 2.644; 2.513; 2.687; 2.669; 2.510 | — |
| SECONDARY Trough FEV1 After 21 Days of Treatment |
2.623; 2.6046; 2.4998 | <0.0001 sig |
Eligibility Criteria
Key Inclusion criteria
- Male and female adult patients ≥ 18 years old and ≤ 75 years.
- Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening).
- Patients who have used ICS and LABA combinations for asthma for at least 3 month and at a stable medium or high dose of ICS for at least 1 month prior to Visit 1 (Screening).
- Pre-bronchodilator FEV1 of 9% at screening).
- Patients who have a clinically significant ECG abnormality at Visit 1
- Patients with a history of hypersensitivity or intolerance to any of the study drugs (including excipients)
- Patients with narcolepsy and/or insomnia.
- Patients on Maintenance Immunotherapy (desensitization) for allergies for less than 3 months prior to Visit 2 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 2 but expected to change throughout the course of the study.
- Pregnant or nursing (lactating) women
- Women of child-bearing potential must use Highly effective contraception methods
- Patients who have discontinued LAMA therapy in the past for any safety, tolerability or perceived lack of efficacy reason.
- History of paradoxical bronchospasm in response to inhaled medicines.
- Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
- Patient with a serum potassium level below the laboratory limit of normal at screening.
Data sourced from ClinicalTrials.gov (NCT03063086). 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.