A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: Indacaterol and glycopyrronium (QVA149); Drug: Tiotropium

• Registration Number: NCT02566031
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

To demonstrate superiority of QVA149 (110/50 μg) once daily compared to tiotropium 18 μg once daily in terms of trough forced expiratory volume in 1 second (FEV1) (mean of 45 min and 15 min pre-dose) following 12 weeks of treatment in mild to moderate symptomatic COPD patients

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-23
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Results First Submitted: 2019-06-02
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

• Confirmed diagnosis of COPD and post-bronchodilator FEV1 ≥ 50% of the predicted normal value and post-bronchodilator FEV1/FVC < 0.7 (COPD Grade 1 or 2 by severity of airflow limitation (GOLD 2015)
• Patients with CAT score ≥ 10 at Visit 0 and Visit 1.
• Patients who are on and have been on tiotropium monotherapy for the past 3 months.
• 0 or 1 COPD exacerbation in the previous 12 months (not leading to hospital admission).

Exclusion Criteria

• Treatment with any inhaled corticosteroid (ICS) in the 3 months prior to Visit 1.
• COPD exacerbation between Visit 0 and 1.
• Patients with concomitant pulmonary disease
• Patients with a history of respiratory infection within 4 weeks prior to Visit 0.
• Prior or current diagnosis of asthma.
• Presence of any contraindication, warning, precaution, hypersensitivity to LABA and LAMA

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indacaterol and glycopyrronium (QVA149)	Indacaterol and glycopyrronium (QVA149)	QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks
Tiotropium	Tiotropium	Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks

Primary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment	Week 12	Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.

Secondary Outcome Measures

Name	Time	Method
Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment	mean of 45 min and 15 min pre-dose week 4	Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values.
Baseline Transitional Dyspnea Index (TDI) Focal Score	Week 12	A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. TDI captures changes from baseline, each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.
Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)	Week 12	Total score of COPD Assessment Test (CAT) will be measured at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. Mild: Score = 0 - 10, Moderate: Score = 11 - 20, Severe: Score = 21 - 30, Very Severe: Score = 31 - 40. The CAT total score was the sum of 8 item scores (each ranging from 0 to 5). If 1 or 2 items were missing, they were replaced with the mean of the completed items. If 3 or more items were missing, the CAT total score was set missing
Daily Rescue Medication Use (Number of Puffs)	Week 12	The total number of puffs of rescue medication used over the last 24 hours will be recorded in the patient diary in the morning. The total number of puffs of rescue medication per day over the full 12 weeks will be calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient. The mean daily number of puffs of rescue medication used over 12 weeks will be summarized by treatments

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Ulsan, Korea, Republic of