QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
Source: ClinicalTrials.gov NCT02634983 ↗Summary
Linked Publications
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Effect of indacaterol/glycopyrronium on ventilation and perfusion in COPD: a randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Ventilated Lung Volume |
61.73; 56.73 | 0.0254 sig |
| SECONDARY Regional Ventilated Lung Volume |
61.94; 57.16; 58.97; 54.01; 64.17; 59.20 | 0.0350 sig |
| SECONDARY Pulmonary Perfusion |
13.96; 13.03; 14.42; 13.08; 13.48; 12.79 | 0.3230 |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
1.27; 1.13; 1.32; 1.12; 1.34; 1.15 | <0.0001 sig |
| SECONDARY Forced Vital Capacity (FVC) |
2.92; 2.68; 2.99; 2.63; 2.99; 2.68 | <0.0001 sig |
| SECONDARY FEV1/FVC Ratio |
44.31; 42.14; 44.97; 42.91; 45.25; 42.93 | 0.0006 sig |
| SECONDARY Lung Clearance Index by Multiple Breath Nitrogen Washout (MBNW) |
10.80; 10.81 | 0.9820 |
| SECONDARY Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) |
16.38; 15.73 | 0.0821 |
Eligibility Criteria
Key Inclusion Criteria
Males and females with COPD aged 40 years and above, weighing ≥45 kg and ≤100 kg, who were smokers and ex-smokers who had a smoking history of at least 10 pack years, and diagnosed with moderate to severe COPD according to GOLD 2015 criteria were included in the study. Patients with airflow limitation indicated by a post-bronchodilator FEV1/FVC < 0.70 and by a post-bronchodilator FEV1 ≥ 30 % and <80 % were included in the study. Post-bronchodilator refers to 1 hr (+/- 5 minutes) after sequential inhalation of 84 µg ipratropium bromide (or equivalent dose) and 400 µg salbutamol/360 µg albuterol (or equivalent dose).
Key Exclusion Criteria
Patients with conditions which could compromise patient safety and compliance (as judged by the investigator), as well as conditions that required oxygen therapy for chronic hypoxemia, ≥25% emphysematous changes on a scan within 6 months to screening, those with lower respiratory infections within 6 weeks of screening, and patients with concomitant pulmonary disease were excluded from the study. Patients with asthma were also excluded from the study.
Pregnant or nursing (lactating) women, patients with poorly controlled Type I or Type II diabetes, patients with poor renal function, and those who were unable to use a dry powder inhaler or perform spirometry, and had contraindications to MRI were also excluded.
Data sourced from ClinicalTrials.gov (NCT02634983) 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.