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

NCT ID: NCT01709903

Last Updated: 2015-03-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-02-28

Brief Summary

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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

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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QVA149

QVA149 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

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

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

Placebo to fluticasone/salmeterol

Intervention Type DRUG

Placebo to fluticasone/salmeterol with Accuhaler

fluticasone/salmeterol

Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device

Group Type ACTIVE_COMPARATOR

Fluticasone/salmeterol

Intervention Type DRUG

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

Placebo to QVA149

Intervention Type DRUG

Placebo to QVA149 with SDDPI

Interventions

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QVA149

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

Intervention Type DRUG

Fluticasone/salmeterol

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

Intervention Type DRUG

Placebo to QVA149

Placebo to QVA149 with SDDPI

Intervention Type DRUG

Placebo to fluticasone/salmeterol

Placebo to fluticasone/salmeterol with Accuhaler

Intervention Type DRUG

Other Intervention Names

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Experimental: QVA149 Comparator: Fluticasone/salmeterol Experimental: QVA149 Comparator: fluticasone/salmeterol

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Caba, Buenos Aires, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, Argentina

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Novartis Investigative Site

La Plata, Buenos Aires, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

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Novartis Investigative Site

Rojas, Buenos Aires, Argentina

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Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

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Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Novartis Investigative Site

Viña del Mar, Vina Del Mar, Chile

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Novartis Investigative Site

Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Novartis Investigative Site

Nanning, Guangxi, China

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Shijiazhuang, Hebei, China

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Changsha, Hunan, China

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Nanjing, Jiangsu, China

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Suzhou, Jiangsu, China

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Nanchang, Jiangxi, China

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Shengyang, Liaoning, China

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Shenyang, Liaoning, China

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Qingdao, Shandong, China

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Shanghai, Shanghai Municipality, China

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Novartis Investigative Site

Xi’an, Shanxi, China

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Xi’an, Shanxi, China

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Chengdu, Sichuan, China

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Hangzhou, Zhejiang, China

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Hangzhou, Zhejiang, China

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Novartis Investigative Site

Hangzhou, Zhejiang, China

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Novartis Investigative Site

Beijing, , China

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Novartis Investigative Site

Beijing, , China

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Novartis Investigative Site

Beijing, , China

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Beijing, , China

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Beijing, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Chongqing, , China

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Novartis Investigative Site

Jiangyin, , China

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Novartis Investigative Site

Nanjing, , China

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Novartis Investigative Site

Shanghai, , China

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Novartis Investigative Site

Shanghai, , China

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Shanghai, , China

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Novartis Investigative Site

Niaosong Township, Taiwan, Taiwan

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Novartis Investigative Site

Taichung, Taiwan, Taiwan

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Novartis Investigative Site

Taipei County, Taiwan, Taiwan

Site Status

Novartis Investigative Site

Taipei, Taiwan, ROC, Taiwan

Site Status

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Lin-Ko, , Taiwan

Site Status

Countries

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Argentina Chile China Taiwan

References

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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.

Reference Type DERIVED
PMID: 27715335 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26082625 (View on PubMed)

Other Identifiers

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CQVA149A2331

Identifier Type: -

Identifier Source: org_study_id

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