Phase 3
N=148
Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03137784 ↗Enrolled (actual)
148
Serious AEs
0.5%
Results posted
Jan 2019
Primary outcome: Primary: Trough FEV1 After One Week of Treatment, Point Estimate — 2.392; 2.392; 2.303 Liters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NVA237 (glycopyrronium bromide) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough FEV1 After One Week of Treatment, Point Estimate |
2.392; 2.392; 2.303 | <0.001 sig |
| SECONDARY FEV1 AUC (5 Min-1 h) After One Week of Treatment |
2.489; 2.492; 2.324 | <0.001 sig |
| SECONDARY FEV1 AUC (5 Min-4 h) After One Week of Treatment |
2.522; 2.525; 2.346 | <0.001 sig |
| SECONDARY FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment |
2.443; 2.450; 2.304 | <0.001 sig |
| SECONDARY Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment |
2.621; 2.630; 2.457 | <0.001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) After 1 Week of Treatment |
3.509; 3.530; 3.472 | 0.079 |
| SECONDARY Percent Change From Baseline in FEV1/FVC Ratio |
0.018; 0.016; 0.003 | — |
| SECONDARY Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period |
395.09; 393.87; 369.58 | <0.001 sig |
| SECONDARY Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment |
409.66; 408.08; 378.72 | <0.001 sig |
| SECONDARY Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment |
0.98; 1.02; 1.13 | 0.053 |
Summary
The purpose of this trial is to characterize the bronchodilator effects and safety of 25 ug and 50 ug o.d. NVA237 (glycopyrronium bromide) doses compared to placebo in asthma patients
Eligibility Criteria
Inclusion Criteria
- Male and female adult patients aged >= 18 or = = 4 weeks
- Pre-bronchodilator FEV1 of >= 50% and = = 200 ml during reversibility testing
Key Exclusion Criteria
- Patients who have had an asthma exacerbation that required either treatment with systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital treatment within 6 weeks prior to screening and patients with a history of life-threatening asthma attacks
- Patients who have had a respiratory tract infection within 4 weeks prior to screening.
- Patients who have smoked or inhaled tobacco products within the past 6 month of screening.
- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by imaging).
- Patients on Maintenance Immunotherapy (desensitization) for allergies for at least 3 months prior to Run-in who are expected to change therapy throughout the course of the study.
- Patients who during the Run-in period are shown to be intolerable to LABA withdrawal.
- Patients who have discontinued LAMA therapy in the past (e.g. due to intolerance or perceived lack of efficacy).
Data sourced from ClinicalTrials.gov (NCT03137784). 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.