Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (FLASH)
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|ClinicalTrials.gov Identifier: NCT02516592|
Recruitment Status : Completed
First Posted : August 6, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: QVA149 110/50 micrograms Drug: Salmeterol/fluticasone 50/500 microgrammes||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Switching From Salmeterol/Fluticasone to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic COPD Patients|
|Actual Study Start Date :||October 13, 2015|
|Actual Primary Completion Date :||May 4, 2017|
|Actual Study Completion Date :||May 4, 2017|
Experimental: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. Capsules for inhalation
Drug: QVA149 110/50 micrograms
QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
Active Comparator: salmeterol/fluticasone 50/500 micrograms
salmeterol/fluticasone 50/500 micrograms b.i.d. Dry inhalation powder
Drug: Salmeterol/fluticasone 50/500 microgrammes
Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
- Change From Baseline in Trough Pre-dose FEV1 in Both Arms [ Time Frame: Baseline, week 12 ]Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).
- Transitional Dyspnea Index (TDI) Focal Score [ Time Frame: Baseline, week 12 ]Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.
- Change From Baseline in FVC (Forced Vital Capacity) [ Time Frame: week 12 ]Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1
- Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test) [ Time Frame: week 12 ]The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.
- Change From Baseline in Mean Daily Use of Rescue Medication [ Time Frame: over 12 weeks ]Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516592