Chronic Obstructive Pulmonary DiseasePhase 3NCT02487498
Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
A Phase 3 study testing QVA149 and Umeclidinium/vilanterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 53 sites in United States.
Trial summary
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- QVA149 and Umeclidinium/vilanterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- 53 sitesUnited States
- Study dates
- 27 Jul 2015to 6 Sep 2016
- 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 or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- Modified Medical Research Council questionnaire grade of 2 or higher
Who cannot join
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Show all 9Show fewer
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Novartis Investigative Site
Amarillo, Texas, 79106-4165
Novartis Investigative Site
Anaheim, California, 92801
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Boerne, Texas, 78006
Novartis Investigative Site
Charleston, South Carolina, 29406-7108
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Chiefland, Florida, 32626
Novartis Investigative Site
Cincinnati, Ohio, 45231
Novartis Investigative Site
Cincinnati, Ohio, 45245
Novartis Investigative Site
Clearwater, Florida, 33765
Novartis Investigative Site
Easley, South Carolina, 29640
Novartis Investigative Site
El Paso, Texas, 79903
Novartis Investigative Site
Escondido, California, 92025
Novartis Investigative Site
Eugene, Oregon, 97404
Novartis Investigative Site
Florence, Kentucky, 41042
Novartis Investigative Site
Fort Mill, South Carolina, 29707
Novartis Investigative Site
Fort Worth, Texas, 76104
Novartis Investigative Site
Gaffney, South Carolina, 29340
Novartis Investigative Site
Gainesville, Florida, 32607
Novartis Investigative Site
Gastonia, North Carolina, 28054
Novartis Investigative Site
Greenfield, Wisconsin, 53228
Novartis Investigative Site
Greenville, South Carolina, 29615
Novartis Investigative Site
Kingwood, Texas, 77339
Novartis Investigative Site
Lincoln, Nebraska, 68510
Novartis Investigative Site
Livonia, Michigan, 48152
Novartis Investigative Site
Miami, Florida, 33144
Novartis Investigative Site
Miami, Florida, 33169
Novartis Investigative Site
Monroe, North Carolina, 28112
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
New Bern, North Carolina, 28562
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Omaha, Nebraska, 68134
Novartis Investigative Site
Owensboro, Kentucky, 42303
Novartis Investigative Site
Plano, Texas, 75093
Novartis Investigative Site
Pottstown, Pennsylvania, 19464
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Richmond, Virginia, 23225
Novartis Investigative Site
Riverside, California, 92506
Novartis Investigative Site
Rock Hill, South Carolina, 29732
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
San Antonio, Texas, 78299
Novartis Investigative Site
San Diego, California, 92103-8415
Novartis Investigative Site
San Diego, California, 92117
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
Seneca, South Carolina, 29678
Novartis Investigative Site
Shelby, North Carolina, 28150
Novartis Investigative Site
Simpsonville, South Carolina, 29681
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Union, South Carolina, 29379
Novartis Investigative Site
Wilmington, North Carolina, 28401
Novartis Investigative Site
Winter Park, Florida, 32789
About this study
Official title: A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- QVA149, Umeclidinium/vilanterol, Placebo (umeclidinium/vilanterol ), Placebo (QVA149)
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- 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 capsules for inhalation, delivered via QVA149 SDDPI
Umeclidinium/vilanterolDrug
Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Placebo (umeclidinium/vilanterol )Drug
Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
Placebo (QVA149)Drug
Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
| Study group | Role | What they receive |
|---|---|---|
| QVA149 | Experimental | QVA149 capsules for inhalation, delivered via QVA149 SDDPI Receives: Drug: QVA149; Drug: Placebo (umeclidinium/vilanterol ) |
| Umeclidinium/vilanterol | Experimental | Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler Receives: Drug: Umeclidinium/vilanterol; Drug: Placebo (QVA149) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Measured: baseline, 0 to 24 hours post-dose at week 12
Secondary outcomes (8)
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
Measured: baseline, 0 to 24 hours post-dose at week 12
Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment.
Measured: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
Change From Baseline in FEV1 AUC 12-24h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).
Measured: baseline, 12 hours to 24 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-12h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).
Measured: baseline, 0 to 12 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.
Measured: baseline, 12 weeks
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.
Measured: baseline, 12 weeks
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measured: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measured: Day 1 (5min, 15min, 30 min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start27 Jul 2015
- Primary completion6 Sep 2016
- Study completion6 Sep 2016
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487498
- Sponsor's protocol ID
- CQVA149A2350
- Status last verified
- Mar 2018
- First submitted
- 29 Jun 2015
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.
PubMed 28993871
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, Two-period Cross-over Study to Assess the Efficacy, Safety and Tolerability of Indacaterol Maleate/Glycopyrronium Bromide Compared to Umeclidinium Bromide/Vilanterol in COPD Patients With Moderate to Severe Airflow Limitation.
- ClinicalTrials.gov ID
- NCT02487498
- Acronym / sponsor ID
- CQVA149A2350
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 6 Sep 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 2 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QVA149 | Experimental | Drug: QVA149, Drug: Placebo (umeclidinium/vilanterol )QVA149 capsules for inhalation, delivered via QVA149 SDDPI |
| Umeclidinium/vilanterol | Experimental | Drug: Umeclidinium/vilanterol, Drug: Placebo (QVA149)Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler |
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 or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
- Modified Medical Research Council questionnaire grade of 2 or higher
Key exclusion criteria (9 listed)
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
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 capsules for inhalation, delivered via QVA149 SDDPI | Drug | QVA149 |
| Umeclidinium/vilanterolUmeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler | Drug | Umeclidinium/vilanterol |
| Placebo (umeclidinium/vilanterol )Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler | Drug | QVA149 |
| Placebo (QVA149)Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI | Drug | Umeclidinium/vilanterol |
Primary outcome
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time frame: baseline, 0 to 24 hours post-dose at week 12
FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.
8 secondary outcomes
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h
Time frame: baseline, 0 to 24 hours post-dose at week 12
Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)
Time frame: baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12
Change From Baseline in FEV1 AUC 12-24h
Time frame: baseline, 12 hours to 24 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-12h
Time frame: baseline, 0 to 12 hours post-dose at week 12
Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h
Time frame: baseline, 12 weeks
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)
Time frame: baseline, 12 weeks
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point
Time frame: Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point
Time frame: Day 1 (5min, 15min, 30 min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28993871Kerwin E, Ferguson GT, Sanjar S, Goodin T, Yadao A, Fogel R, Maitra S, Sen B, Ayers T, Banerji D. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies. Lung. 2017 Dec;195(6):739-747. doi: 10.1007/s00408-017-0055-9. Epub 2017 Oct 9.
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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.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QVA149 and Umeclidinium/vilanterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 53 sites in United States.
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 9 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. 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 2 Apr 2018). 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?
Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h (time frame: baseline, 0 to 24 hours post-dose at 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 NCT02487498, 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 2 Apr 2018.