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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566031
• Other study ID #: CQVA149AKR01
• Status: Completed
• Phase: Phase 4
• Start date: March 23, 2013
• Est. completion date: June 4, 2018

Study information

• Verified date: August 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Indacaterol and glycopyrronium (QVA149)
Capsules for inhalation delivered via SDDPI
• Tiotropium
Capsules for inhalation delivered via HandiHaler® device

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Anyang-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Chuncheon	Gangwon-do
Korea, Republic of	Novartis Investigative Site	Guri-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Jeju
Korea, Republic of	Novartis Investigative Site	Jeonju-si	Jeollabuk-do
Korea, Republic of	Novartis Investigative Site	Koyang	Kyunggi
Korea, Republic of	Novartis Investigative Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Suwon-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Ulsan
Korea, Republic of	Novartis Investigative Site	Wonju	Gangwon-Do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment	Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.	Week 12
Secondary	Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment	Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values.	mean of 45 min and 15 min pre-dose week 4
Secondary	Baseline Transitional Dyspnea Index (TDI) Focal Score	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.	Week 12
Secondary	Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)	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	Week 12
Secondary	Daily Rescue Medication Use (Number of Puffs)	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	Week 12