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Chronic Obstructive Pulmonary DiseasePhase 3NCT01709903

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

A Phase 3 study testing QVA149 and Fluticasone/salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 55 sites in 4 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

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD 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 Fluticasone/salmeterol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
744 participants
Where
55 sitesin 4 countries
Study dates
Nov 2012to Feb 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

  • Patients with moderate to severe stable COPD (Stage II or Stage III) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline.
  • Current or ex-smokers who have a smoking history of at least 10 pack years. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7.
  • Modified Medical Research Council (mMRC) grade of at least 2 at Visit 2.

Who cannot join

  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test.
  • Patents with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH), bladder-neck obstruction, moderate to severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered.
  • Patients with a history of long QT syndrome or whose QTc measured at run-in (Visit 2) (Fridericia method) is prolonged (>450 ms for males and females) as confirmed by the central Electrocardiogram (ECG) assessor.
  • Patients with Type I or uncontrolled Type II diabetes. Patients who have not achieved spirometry result at Visit 2 in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria for acceptability and repeatability.
  • Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.
  • Patients with concomitant pulmonary disease (e.g. lung fibrosis, primary bronchiectasis, sarcoidosis, interstitial lung disorder, pulmonary hypertension).
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

55 sites in 4 countries.

55 sites in 4 countries

China33 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100023

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100020

  • Novartis Investigative Site

    Beijing, 100029

  • Novartis Investigative Site

    Beijing, 100034

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Beijing

  • Novartis Investigative Site

    Changsha, Hunan, 410003

  • Novartis Investigative Site

    Changsha, Hunan, 410011

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Chongqing, 400038

  • Novartis Investigative Site

    Chongqing, 400042

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310016

  • Novartis Investigative Site

    Jiangyin

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Nanjing

  • Novartis Investigative Site

    Nanning, Guangxi, 530021

  • Novartis Investigative Site

    Qingdao, Shandong, 266011

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200433

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Shanghai, 200433

  • Novartis Investigative Site

    Shengyang, Liaoning, 110016

  • Novartis Investigative Site

    Shenyang, Liaoning

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004

  • Novartis Investigative Site

    Wuhan, Hubei, 430022

  • Novartis Investigative Site

    Xi’an, Shanxi, 710032

  • Novartis Investigative Site

    Xi’an, Shanxi, 710061

Other trials in China

Argentina12 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1125ABE

  • Novartis Investigative Site

    Caba, Buenos Aires, 1122

  • Novartis Investigative Site

    Caba, Buenos Aires, B8000XAV

  • Novartis Investigative Site

    Caba, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    Caba, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Caba, Buenos Aires, C1424BSF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1425BEN

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH

  • Novartis Investigative Site

    La Plata, Buenos Aires, 1900

  • Novartis Investigative Site

    Mar del Plata, Buenos Aires, 7600

  • Novartis Investigative Site

    Rojas, Buenos Aires, B2705XAE

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

Other trials in Argentina

Taiwan6 sites

  • Novartis Investigative Site

    Kaohsiung City, 81346

  • Novartis Investigative Site

    Lin-Ko, 33305

  • Novartis Investigative Site

    Niaosong Township, Taiwan, 83301

  • Novartis Investigative Site

    Taichung, Taiwan, 40705

  • Novartis Investigative Site

    Taipei, Taiwan, ROC, 112

  • Novartis Investigative Site

    Taipei County, Taiwan

Other trials in Taiwan

Chile4 sites

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8431633

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, Piso 1

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan

  • Novartis Investigative Site

    Viña del Mar, Vina Del Mar, 2520024

Other trials in Chile

About this study

Official title: A 26-week Treatment Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy and Safety of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe COPD

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

Read the detailed description

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.

The study population will consist of approximate 736 male and female adults (age 40 years and greater) with a clinical diagnosis of stable COPD [GOLD (2010)] and a smoking history of at least 10 pack years. It is anticipated that approximately 981 patients will need to be screened in order to randomize 736 patients into 2 treatment arms of the study with an equal randomization ratio, meaning QVA149 (368 patients), fluticasone/salmeterol (368 patients). Treatment randomization will be stratified by current/ex-smoker status and prior ICS use. It is intended that 552 patients will complete the study at Week 26 without major protocol deviations. Dropouts will not be replaced.

This will be a multi-national study, including China, and at least two other countries.

Standardization FEV1 AUC0-12h will be performed in a subgroup of around 100 patients (50 patients per treatment arm) in pre-selected centers.

Being tested
QVA149, Fluticasone/salmeterol, Placebo to QVA149, Placebo to fluticasone/salmeterol
Keywords
chronic obstructive pulmonary disease
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 Experimental: QVA149

    QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI).

  • Fluticasone/salmeterolDrug

    Also called Comparator: Fluticasone/salmeterol

    Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device.

  • Placebo to QVA149Drug

    Also called Experimental: QVA149

    Placebo to QVA149 with SDDPI

  • Placebo to fluticasone/salmeterolDrug

    Also called Comparator: fluticasone/salmeterol

    Placebo to fluticasone/salmeterol with Accuhaler

Study groups in NCT01709903
Study groupRoleWhat they receive
QVA149ExperimentalQVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
Receives: Drug: QVA149; Drug: Placebo to fluticasone/salmeterol
fluticasone/salmeterolActive comparatorFluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
Receives: Drug: Fluticasone/salmeterol; Drug: Placebo to QVA149

What is being measured

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

  1. Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d

    Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.

    Measured: 26 weeks

Secondary outcomes (8)

  1. Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d

    Measured: 26 weeks

  2. Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours

    Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.

    Measured: Day 1, 12 and 26 weeks

  3. Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period

    Average of Trough Forced Expiratory Volume in one second (FEV1)

    Measured: 6,12,18 and 26 weeks

  4. Analysis of Trough FVC (L) Over the Whole Treatment Period

    Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose

    Measured: 12 and 26 weeks

  5. Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment

    A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.

    Measured: 26 weeks

  6. Analysis of the TDI Focal Score Over the Whole Treatment Period

    The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. ."Baseline 12 weeks" and "Baseline 26 weeks", were the baseline scores for available participants analyzed for each time point.

    Measured: 12 and 26 weeks

  7. Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals

    The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. "Baseline 12 weeks" and "Baseline 26 weeks", were the baseline scores for available participants analyzed for each time point. Less puffs taken is better.

    Measured: 12 and 26 weeks

  8. Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment

    Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)

    Measured: 26 weeks

Timeline

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

  1. First posted18 Oct 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01709903
Sponsor's protocol ID
CQVA149A2331
Status last verified
Mar 2015
First submitted
16 Oct 2012
Last updated
17 Mar 2015
Data monitoring committee
No

Publications

  • Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Patalano F, Banerji D. Efficacy and Safety of Indacaterol/Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: The Chinese Cohort from the LANTERN Study. COPD. 2016 Dec;13(6):686-692. doi: 10.1080/15412555.2016.1182970. Epub 2016 Aug 11.

    PubMed 27715335

  • Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Thach C, Patalano F, Banerji D; LANTERN Investigators. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 5;10:1015-26. doi: 10.2147/COPD.S84436. eCollection 2015.

    PubMed 26082625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149 and Fluticasone/salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 55 sites in 4 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 3 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in China, Argentina, Taiwan, Chile. 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 17 Mar 2015). 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) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (time frame: 26 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 NCT01709903, which also lists 2 linked publications.

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 17 Mar 2015.

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