Phase 4
Completed N=502
Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort
Source: ClinicalTrials.gov NCT02516592 ↗Enrolled (actual)
502
Serious AEs
3.6%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Trough Pre-dose FEV1 in Both Arms — 0.036; -0.009 Liters — p=0.028
◆ Published Evidence
Established
26citations · ~3 / year
Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial.
Summary
This study will investigate whether switching symptomatic COPD patients from a fixed-dose combination of salmeterol/fluticasone 50/500 µg b.i.d. to a fixed dose combination of QVA149 110/50 µg o.d. leads to improved lung function and airflow. It will also assess the effect on symptom burden, breathlessness, and use of rescue medication after this switch.
Linked Publications
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Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Pre-dose FEV1 in Both Arms |
0.036; -0.009 | 0.028 sig |
| SECONDARY Transitional Dyspnea Index (TDI) Focal Score |
3.24; 2.79 | 0.063 |
| SECONDARY Change From Baseline in FVC (Forced Vital Capacity) |
0.073; -0.028 | 0.002 sig |
| SECONDARY Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test) |
13.4; 13.8 | 0.319 |
| SECONDARY Change From Baseline in Mean Daily Use of Rescue Medication |
1.05; 1.09 | 0.662 |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed.
- Male and female ≥ 40 years
- Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack years are defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at visit 1
- Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 30% and 12 hours per day
- Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
Data sourced from ClinicalTrials.gov (NCT02516592) 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.