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Chronic Obstructive Pulmonary DiseasePhase 3NCT02487446

Efficacy and Safety Study of QVA149 in COPD Patients

A Phase 3 study testing QVA149 and Umeclidinium/vilanterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 58 sites in United States.

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

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
357 participants
Where
58 sitesUnited States
Study dates
28 Jul 2015to 12 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

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Novartis Investigative Site

    Altamonte Springs, Florida, 32701

  • Novartis Investigative Site

    Andalusia, Alabama, 36305

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Carrollton, Texas, 75010

  • Novartis Investigative Site

    Channelview, Texas, 77530

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80907

  • Novartis Investigative Site

    Columbia, Maryland, 21044

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Conyers, Georgia, 30094

  • Novartis Investigative Site

    Cornelius, North Carolina, 28031

  • Novartis Investigative Site

    DeLand, Florida, 32720

  • Novartis Investigative Site

    Dublin, Ohio, 43016

  • Novartis Investigative Site

    Duluth, Georgia, 30096

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    Fayetteville, Arkansas, 72703

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33316-192

  • Novartis Investigative Site

    Fort Worth, Texas, 76109

  • Novartis Investigative Site

    Fridley, Minnesota, 55432

  • Novartis Investigative Site

    Gastonia, North Carolina, 28054

  • Novartis Investigative Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Hickory, North Carolina, 28602

  • Novartis Investigative Site

    High Point, North Carolina, 27262

  • Novartis Investigative Site

    Huntersville, North Carolina, 28078

  • Novartis Investigative Site

    Huntington Beach, California, 92647

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Kissimmee, Florida, 34741

  • Novartis Investigative Site

    Lampasas, Texas, 76550

  • Novartis Investigative Site

    Marion, Ohio, 43302

  • Novartis Investigative Site

    McKinney, Texas, 75069

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigative Site

    Meridian, Idaho, 83642

  • Novartis Investigative Site

    Miami, Florida, 33172

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407

  • Novartis Investigative Site

    Multiple Locations, Alabama

  • Novartis Investigative Site

    Multiple Locations, Arizona

  • Novartis Investigative Site

    New Braunfels, Texas, 78130

  • Novartis Investigative Site

    New Orleans, Louisiana, 70119

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Pensacola, Florida, 32503

  • Novartis Investigative Site

    Pensacola, Florida, 32504

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19142

  • Novartis Investigative Site

    Plymouth, Minnesota, 55441

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Rancho Mirage, California, 92270

  • Novartis Investigative Site

    Salt Lake City, Utah, 84102

  • Novartis Investigative Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    Sunset, Louisiana, 70584

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tempe, Arizona, 85283

  • Novartis Investigative Site

    Tipton, Pennsylvania, 16684

  • Novartis Investigative Site

    Tucson, Arizona, 85723

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Double-blind, Double-dummy, Active Controlled, 2-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.

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

    Also called Indecaterol maleate/glycopyrronium bromide

    QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)

  • Umeclidinium/vilanterolDrug

    Also called ELLIPTA®

    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 groups in NCT02487446
Study groupRoleWhat they receive
First QVA149, then Umeclidinium/vilanterolExperimentalParticipants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks.
Receives: Drug: QVA149; Drug: Umeclidinium/vilanterol; Drug: Placebo (umeclidinium/vilanterol); Drug: Placebo (QVA149)
First Umeclidinium/vilanterol, then QVA149ExperimentalParticipants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
Receives: Drug: QVA149; Drug: Umeclidinium/vilanterol; Drug: Placebo (umeclidinium/vilanterol); Drug: Placebo (QVA149)

What is being measured

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

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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, 15 minutes and 45 minutes pre morning dose at week 12

  7. 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)

  8. 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, 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)

Timeline

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

  1. First posted1 Jul 2015 (estimated)
  2. Study start28 Jul 2015
  3. Primary completion12 Sep 2016
  4. Study completion12 Sep 2016

Resources

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
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487446
Sponsor's protocol ID
CQVA149A2349
Status last verified
Nov 2017
First submitted
29 Jun 2015
Last updated
26 Dec 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

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 58 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 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 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 26 Dec 2017). 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 NCT02487446, 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 26 Dec 2017.

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