Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01682863

A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

A Phase 3 study testing QVA149 and QAB149 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 86 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: QVA149 and QAB149
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 614 participants
Where: 86 sitesin 7 countries
Study dates: Oct 2012to Jun 2014
Phase: Phase 3
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

Male and female adults aged ≥40 years
Patients with stable COPD according to GOLD strategy (GOLD 2011).
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC ≥ grade 2

Who cannot join

History of long QT syndrome or prolonged QTc
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
Patients with Type I or uncontrolled Type II diabetes
Patients with a history of asthma or have concomitant pulmonary disease
Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
Other protocol defined inclusion/exclusion criteria may apply

Trial locations and contacts

86 sites in 7 countries.

Country

City, postcode or hospital

86 sites in 7 countries

United States47 sites

Novartis Investigative Site
Abingdon, Virginia, 24210
Novartis Investigative Site
Ames, Iowa, 50010
Novartis Investigative Site
Baltimore, Maryland, 21224
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Boulder, Colorado, 80304
Novartis Investigative Site
Bowling Green, Kentucky, 42101
Novartis Investigative Site
Corsicana, Texas, 75110
Novartis Investigative Site
Dayton, Ohio, 45459
Novartis Investigative Site
Dublin, Ohio, 43016
Novartis Investigative Site
Eugene, Oregon, 97404
Novartis Investigative Site
Evansville, Indiana, 47712
Novartis Investigative Site
Fort Worth, Texas, 76104
Novartis Investigative Site
Henderson, Nevada, 89014
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Iowa City, Iowa, 52240
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Knoxville, Tennessee, 37912
Novartis Investigative Site
Lakewood, California, 90712-151
Novartis Investigative Site
Las Vegas, Nevada, 89119
Novartis Investigative Site
Lincoln, Nebraska, 68506
Novartis Investigative Site
Livonia, Michigan, 48152
Novartis Investigative Site
Lombard, Illinois, 60148
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Lufkin, Texas, 75904
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Medford, Oregon, 97504-8741
Novartis Investigative Site
Midlothian, Virginia, 23114
Novartis Investigative Site
Minneapolis, Minnesota, 55407
Novartis Investigative Site
Missoula, Montana, 59804
Novartis Investigative Site
New Orleans, Louisiana, 70115
Novartis Investigative Site
Newport News, Virginia, 23606
Novartis Investigative Site
O'Fallon, Illinois, 62269
Novartis Investigative Site
Oklahoma City, Oklahoma, 73103
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Peoria, Illinois, 61602
Novartis Investigative Site
Picayune, Mississippi, 39466
Novartis Investigative Site
Rochester, New York, 14618
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
Slidell, Louisiana, 70458
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
Stockton, California, 95207
Novartis Investigative Site
Vestavia Hills, Alabama, 35216
Novartis Investigative Site
Walnut Creek, California, 94598
Novartis Investigative Site
Waterloo, Iowa, 50702

Other trials in United States

Romania10 sites

Novartis Investigative Site
Brasov, Romania, 500281
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, District 1, 11475
Novartis Investigative Site
Bucharest, District 3, 030303
Novartis Investigative Site
Bucharest, District 3, 030317
Novartis Investigative Site
Bucharest, 060011
Novartis Investigative Site
Bucharest, 50554
Novartis Investigative Site
Cluj-Napoca, 400371
Novartis Investigative Site
Constanța, Jud. Constanta, 900002
Novartis Investigative Site
Iași, Jud. Iasi, 700115

Other trials in Romania

Hungary9 sites

Novartis Investigative Site
Budapest, 1046
Novartis Investigative Site
Budapest, 1125
Novartis Investigative Site
Győr, 9024
Novartis Investigative Site
Makó, 6900
Novartis Investigative Site
Nyíregyháza, Hungary, 4400
Novartis Investigative Site
Pécs, 7635
Novartis Investigative Site
Százhalombatta, 2440
Novartis Investigative Site
Szolnok, H-5000
Novartis Investigative Site
Törökbálint, 2045

Other trials in Hungary

Spain8 sites

Novartis Investigative Site
Badalona, Catalonia, 08914
Novartis Investigative Site
Barcelona, Catalonia
Novartis Investigative Site
Canet de Mar, Catalonia, 08360
Novartis Investigative Site
Centelles, Catalonia, 08540
Novartis Investigative Site
Granada, Andalusia, 18014
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Tarragona, Catalonia, 43350
Novartis Investigative Site
Valencia, Valencia, 46015

Other trials in Spain

Bulgaria5 sites

Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Rousse, Bulgaria, 7002
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Varna, Bulgaria, 9010

Other trials in Bulgaria

Finland4 sites

Novartis Investigative Site
Helsinki, Finland, 00029
Novartis Investigative Site
HUS, 00029
Novartis Investigative Site
Pori, FIN-28500
Novartis Investigative Site
Turku, 20521

Other trials in Finland

Puerto Rico3 sites

Novartis Investigative Site
Barceloneta, 00617
Novartis Investigative Site
San Juan, 00909
Novartis Investigative Site
San Juan, 00918

Other trials in Puerto Rico

About this study

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: QVA149, QAB149, Placebo
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
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.

QVA149Drug
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QVA149Drug
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
QAB149Drug
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
PlaceboDrug
To mimic QAB149

Study groups in NCT01682863
Study group	Role	What they receive
QVA149 dose 1	Experimental	QVA149 27.5/12.5 μg capsules Receives: Drug: QVA149
QVA149 dose 2	Experimental	QVA149 27.5/25 μg capsules Receives: Drug: QVA149
QAB149	Active comparator	QAB149 75 μg capsules Receives: Drug: QAB149; Drug: Placebo

What is being measured

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

Number of Patients With Adverse Events, Serious Adverse Events, and Death
The overall rate of adverse events reported from initiation through 30 days post last dose.
Measured: 56 weeks

Secondary outcomes (7)

Time to Premature Discontinuation of Treatment
methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl
Measured: 56 weeks
Change From Baseline in Pre-dose Trough FEV1
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Measured: Day 29, 57,, 85, 141, 197, 253, 309 and 365
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Measured: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Pulmonary function assessments were performed using centralized spirometry according to international standards.
Measured: Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
Measured: 52 weeks
Change From Baseline in Mean Total Daily Symptom Scores
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
Measured: 52 weeks
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
Measured: 52 weeks

Timeline

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

Oct 2012Jun 2014

First posted11 Sep 2012 (estimated)
Study startOct 2012
Primary completionJun 2014
Study completionJun 2014

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.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 614 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01682863
Sponsor's protocol ID: CQVA149A2340
Other IDs: 2012-001998-93
Status last verified: Feb 2016
First submitted: 7 Sep 2012
Last updated: 30 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation
ClinicalTrials.gov ID: NCT01682863
Acronym / sponsor ID: CQVA149A2340
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 614 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 11 Sep 2012 (estimated)
Results: Posted 30 Mar 2016

Clinical summary

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

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
QVA149 dose 1	Experimental	Drug: QVA149QVA149 27.5/12.5 μg capsules
QVA149 dose 2	Experimental	Drug: QVA149QVA149 27.5/25 μg capsules
QAB149	Active comparator	Drug: QAB149, Drug: PlaceboQAB149 75 μg capsules

Who may qualify

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

Key inclusion criteria (5 listed)

Male and female adults aged ≥40 years
Patients with stable COPD according to GOLD strategy (GOLD 2011).
Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with an mMRC ≥ grade 2

Key exclusion criteria (7 listed)

History of long QT syndrome or prolonged QTc
Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
Patients with Type I or uncontrolled Type II diabetes
Patients with a history of asthma or have concomitant pulmonary disease
Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible

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
QVA149QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI	Drug	QVA149 dose 1
QVA149QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI	Drug	QVA149 dose 2
QAB149QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI	Drug	QAB149
PlaceboTo mimic QAB149	Drug	QAB149

Primary outcome

Number of Patients With Adverse Events, Serious Adverse Events, and Death
Time frame: 56 weeks
The overall rate of adverse events reported from initiation through 30 days post last dose.

7 secondary outcomes

Time to Premature Discontinuation of Treatment
Time frame: 56 weeks
Change From Baseline in Pre-dose Trough FEV1
Time frame: Day 29, 57,, 85, 141, 197, 253, 309 and 365
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Time frame: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Time frame: Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Time frame: 52 weeks
Change From Baseline in Mean Total Daily Symptom Scores
Time frame: 52 weeks
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Time frame: 52 weeks

Results and safety

Results posted to the registry on 30 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QVA149 27.5/12.5 ug Bid	204	177
QVA149 27.5/25 ug Bid	204	187
QAB149 75 ug od	207	183

Primary outcome: Number of Patients With Adverse Events, Serious Adverse Events, and Death

Time frame: 56 weeks. Number. Unit: Number of Patients

Measure	QVA149 27.5/12.5 ug Bid n = 204	QVA149 27.5/25 ug Bid n = 204	QAB149 75 ug od n = 206
Patients with at least one SAEs	26	25	24
Patients with at least one AE	139	142	139
Death	1	3	5

Population analysed: The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149 27.5/12.5 ug Bid	26 of 204 (12.7%)	118 of 204 (57.8%)	Not reported
QVA149 27.5/25 ug Bid	25 of 204 (12.3%)	117 of 204 (57.4%)	Not reported
QAB75	24 of 206 (11.7%)	112 of 206 (54.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking

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.

86 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149 and QAB149 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 86 sites in 7 countries.

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 5 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Romania, Hungary, Spain, Bulgaria and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Mar 2016). 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?

Number of Patients With Adverse Events, Serious Adverse Events, and Death (time frame: 56 weeks). 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 NCT01682863.

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 30 Mar 2016.