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

NCT01709903 | Completed Phase 3 Results

• 1 other identifier: CQVA149A2331
• Study Type: interventional
• Target: 744
• Locations: 4 countries
• Sites: 55

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (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.

  26 weeks

Secondary Outcomes (8)

• 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

  26 weeks

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

  Day 1, 12 and 26 weeks

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

  6,12,18 and 26 weeks

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

  12 and 26 weeks

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

  26 weeks

Study Arms (2)

QVA149

EXPERIMENTAL

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

Drug: QVA149; Drug: Placebo to fluticasone/salmeterol

fluticasone/salmeterol

ACTIVE COMPARATOR

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

Drug: Fluticasone/salmeterol; Drug: Placebo to QVA149

Interventions

QVA149 DRUG

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

Also known as: Experimental: QVA149

QVA149

Fluticasone/salmeterol DRUG

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

Also known as: Comparator: Fluticasone/salmeterol

fluticasone/salmeterol

Placebo to QVA149 DRUG

Placebo to QVA149 with SDDPI

Also known as: Experimental: QVA149

fluticasone/salmeterol

Placebo to fluticasone/salmeterol DRUG

Placebo to fluticasone/salmeterol with Accuhaler

Also known as: Comparator: fluticasone/salmeterol

QVA149

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (55)

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1125ABE, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, 1122, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, B8000XAV, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1056ABJ, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1280AEB, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1424BSF, Argentina

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Novartis Investigative Site

Caba, Buenos Aires, C1425BEN, Argentina

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Novartis Investigative Site

La Plata, Buenos Aires, 1900, Argentina

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Novartis Investigative Site

Mar del Plata, Buenos Aires, 7600, Argentina

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Novartis Investigative Site

Rojas, Buenos Aires, B2705XAE, Argentina

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Novartis Investigative Site

Córdoba, Córdoba Province, X5016KEH, Argentina

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Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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Novartis Investigative Site

Santiago, Santiago Metropolitan, 8431633, Chile

Location

Novartis Investigative Site

Santiago, Santiago Metropolitan, Piso 1, Chile

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Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

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Novartis Investigative Site

Viña del Mar, Vina Del Mar, 2520024, Chile

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Novartis Investigative Site

Beijing, Beijing Municipality, 100023, China

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Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

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Novartis Investigative Site

Nanning, Guangxi, 530021, China

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Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

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Novartis Investigative Site

Wuhan, Hubei, 430022, China

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Novartis Investigative Site

Changsha, Hunan, 410003, China

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Novartis Investigative Site

Changsha, Hunan, 410011, China

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Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

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Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

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Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

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Novartis Investigative Site

Shengyang, Liaoning, 110016, China

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Novartis Investigative Site

Shenyang, Liaoning, China

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Novartis Investigative Site

Qingdao, Shandong, 266011, China

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Novartis Investigative Site

Shanghai, Shanghai Municipality, 200433, China

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Novartis Investigative Site

Xi’an, Shanxi, 710032, China

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Novartis Investigative Site

Xi’an, Shanxi, 710061, China

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Novartis Investigative Site

Chengdu, Sichuan, 610041, China

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Novartis Investigative Site

Hangzhou, Zhejiang, 310003, China

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Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

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Novartis Investigative Site

Hangzhou, Zhejiang, 310016, China

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Novartis Investigative Site

Beijing, 100020, China

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Novartis Investigative Site

Beijing, 100029, China

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Novartis Investigative Site

Beijing, 100034, China

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Novartis Investigative Site

Beijing, 100050, China

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Novartis Investigative Site

Beijing, China

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Novartis Investigative Site

Chongqing, 400037, China

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Novartis Investigative Site

Chongqing, 400038, China

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Novartis Investigative Site

Chongqing, 400042, 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, 200032, China

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Novartis Investigative Site

Shanghai, 200080, China

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Novartis Investigative Site

Shanghai, 200433, China

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Novartis Investigative Site

Niaosong Township, Taiwan, 83301, Taiwan

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Novartis Investigative Site

Taichung, Taiwan, 40705, Taiwan

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Novartis Investigative Site

Taipei County, Taiwan, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

Location

Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

Location

Novartis Investigative Site

Lin-Ko, 33305, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 27715335 DERIVED

• 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.

  PMID: 26082625 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

CL (4); CN (33); AR (12); TW (6)