COPDPhase 4NCT02566031

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

A Phase 4 study testing Indacaterol and glycopyrronium (QVA149) and Tiotropium in people with COPD, run by Novartis Pharmaceuticals at 24 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Indacaterol and glycopyrronium (QVA149) and Tiotropium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 379 participants
Where: 24 sitesSouth Korea
Study dates: 23 Mar 2013to 4 Jun 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

South Korea24 sites

Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068
Novartis Investigative Site
Chuncheon, Gangwon-do, 24253
Novartis Investigative Site
Guri-si, Gyeonggi-do, 471-701
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Incheon, 403-720
Novartis Investigative Site
Incheon, 405 760
Novartis Investigative Site
Jeju City, 63241
Novartis Investigative Site
Jeonju, Jeollabuk-do, 561-712
Novartis Investigative Site
Koyang, Kyunggi, 410-719
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 463-712
Novartis Investigative Site
Seoul, Korea, 03312
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, Seocho Gu, 06591
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 04763
Novartis Investigative Site
Seoul, 05030
Novartis Investigative Site
Seoul, 06273
Novartis Investigative Site
Seoul, 110-746
Novartis Investigative Site
Seoul, 150-713
Novartis Investigative Site
Seoul, 156-707
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Novartis Investigative Site
Ulsan, 44033
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426

Other trials in South Korea

About this study

Conditions: COPD
Being tested: Indacaterol and glycopyrronium (QVA149), Tiotropium
Keywords: COPD, open-label, QVA149, symptomatic, tiotropium
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02566031
Study group	Role	What they receive
Indacaterol and glycopyrronium (QVA149)	Experimental	QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDPPI) for 12 weeks Receives: Drug: Indacaterol and glycopyrronium (QVA149)
Tiotropium	Active comparator	Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks Receives: Drug: Tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12

Secondary outcomes (4)

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.
Measured: mean of 45 min and 15 min pre-dose week 4
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.
Measured: Week 12
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
Measured: Week 12
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
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 20134 Jun 2018

First posted1 Oct 2015 (estimated)
Study start23 Mar 2013
Primary completion4 Jun 2018
Study completion4 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02566031
Sponsor's protocol ID: CQVA149AKR01
Status last verified: Aug 2019
First submitted: 10 Aug 2015
Last updated: 23 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3.
PubMed 28228162

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02566031
Acronym / sponsor ID: CQVA149AKR01
Conditions: COPD
Keywords: COPD, open-label, QVA149, symptomatic, tiotropium
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 379 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 23 Mar 2013 (actual)
Primary completion: 4 Jun 2018 (actual)
Study completion: 4 Jun 2018 (actual)
First posted: 1 Oct 2015 (estimated)
Results: Posted 23 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Indacaterol and glycopyrronium (QVA149)	Experimental	Drug: 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	Active comparator	Drug: TiotropiumTiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 12 weeks

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Indacaterol and glycopyrronium (QVA149)Capsules for inhalation delivered via SDDPI	Drug	Indacaterol and glycopyrronium (QVA149)
TiotropiumCapsules for inhalation delivered via HandiHaler® device	Drug	Tiotropium

Primary outcome

Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment
Time frame: 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.

4 secondary outcomes

Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment
Time frame: mean of 45 min and 15 min pre-dose week 4
Baseline Transitional Dyspnea Index (TDI) Focal Score
Time frame: Week 12
Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)
Time frame: Week 12
Daily Rescue Medication Use (Number of Puffs)
Time frame: Week 12

Results and safety

Results posted to the registry on 23 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indacaterol and Glycopyrronium (QVA149)	189	169
Tiotropium	190	178

Primary outcome: Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment

Time frame: Week 12. Mean (Standard Deviation). Unit: Liters

Measure	Indacaterol and Glycopyrronium (QVA149) n = 177	Tiotropium n = 184
Value	0.0668 (0.18097)	0.0090 (0.18487)

Indacaterol and Glycopyrronium (QVA149) vs Tiotropium: Mean Difference (Net): 0.05 (95% CI 0.011 to 0.093), p = 0.0129, ANCOVA

Population analysed: The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol and Glycopyrronium (QVA149	8 of 189 (4.2%)	12 of 189 (6.3%)	0 of 189
Tiotropium	3 of 188 (1.6%)	9 of 188 (4.8%)	0 of 188
Total	11 of 377 (2.9%)	21 of 377 (5.6%)	0 of 377

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28228162Rhee CK, Park HY, Park JW, Lee JH, Kim TH, Lee SW, Jung JY, Kim S, Hwang YI, Jung KS. Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial. Trials. 2017 Feb 22;18(1):80. doi: 10.1186/s13063-017-1800-3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indacaterol and glycopyrronium (QVA149) and Tiotropium in people with COPD, run by Novartis Pharmaceuticals at 24 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02566031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.