A Study to Assess the Long-term Safety of QVA149

NCT01120717 | Completed Phase 3 Results DMC

• 2 other identifiers: CQVA149A23072009-013235-38
• Study Type: interventional
• Target: 339
• Locations: 10 countries
• Sites: 53

Brief Summary

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

QVA149; COPD; combination bronchodilator

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events or Death

  Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.

  52 weeks + Follow-up (Up to Day 394)

Secondary Outcomes (5)

• Pre-dose FEV1

  52 weeks

• Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period

  52 weeks

• Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period

  52 weeks

• Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period

  52 weeks

• Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period

  52 weeks

Study Arms (2)

QVA149

EXPERIMENTAL

110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)

Drug: QVA149

Placebo

PLACEBO COMPARATOR

Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI

Drug: Placebo

Interventions

QVA149 DRUG

capsules for inhalation, delivered by an SDDPI

QVA149

Placebo DRUG

capsules for inhalation, delivered by an SDDPI

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female adults aged ≥40 yrs
• Smoking history of at least 10 pack years
• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
• Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%

You may not qualify if:

• 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
• Patients in the active phase of a supervised pulmonary rehabilitation program
• Patients contraindicated for inhaled anticholinergic agents and β2 agonists

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (53)

Novartis Investigative Site

Toronto, Ontario, M3H 5S4, Canada

Location

Novartis Investigative Site

Mirabel, Quebec, J7J 2K8, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1G 3Z4, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1P 1J6, Canada

Location

Novartis Investigative Site

Beuvry, France, 62660, France

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Novartis Investigative Site

Ferolles-Attily, France, 77150, France

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Novartis Investigative Site

Montpellier, 34059, France

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Novartis Investigative Site

Nantes, 44000, France

Location

Novartis Investigative Site

Pessac, 33604, France

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Novartis Investigative Site

Aszód, 2170, Hungary

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Novartis Investigative Site

Baja, 6500, Hungary

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Novartis Investigative Site

Érd, 2030, Hungary

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Novartis Investigative Site

Gödöllő, 2100, Hungary

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Novartis Investigative Site

Makó, 6900, Hungary

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Novartis Investigative Site

Chennai - Tamil Nadu, India, 600 087, India

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Novartis Investigative Site

Banglaore, Karnataka, 560027, India

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Novartis Investigative Site

Mysore, Karnataka, 570004, India

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Novartis Investigative Site

Indore, Madhya Pradesh, 452001, India

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Novartis Investigative Site

Mumbai, Maharashtra, 400007, India

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Novartis Investigative Site

New Delhi, National Capital Territory of Delhi, 110029, India

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Novartis Investigative Site

Dehli, New Delhi, 110063, India

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Novartis Investigative Site

Coimbatore, Tamil Nadu, 641044, India

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Novartis Investigative Site

Mangalore, India

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Novartis Investigative Site

Riga, LV, LV-1038, Latvia

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Novartis Investigative Site

Daugavpils, LV-5401, Latvia

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Novartis Investigative Site

Jēkabpils, LV-5201, Latvia

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Novartis Investigative Site

Riga, 1002, Latvia

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Novartis Investigative Site

Alytus, LT-62114, Lithuania

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Novartis Investigative Site

Kaunas, 44320, Lithuania

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Novartis Investigative Site

Klaipėda, 92288, Lithuania

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Novartis Investigative Site

Klaipėda, LT-92231, Lithuania

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Novartis Investigative Site

Vilnius, 06001, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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Novartis Investigative Site

Bucharest, District 1, 011422, Romania

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Novartis Investigative Site

Bucharest, District 1, 10457, Romania

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Novartis Investigative Site

Bucharest, District 3, 030303, Romania

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Novartis Investigative Site

Brasov, Jud. Brasov, 500118, Romania

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Novartis Investigative Site

Iași, Jud. Iasi, 700115, Romania

Location

Novartis Investigative Site

Pretoria, 0184, South Africa

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Novartis Investigative Site

Pretoria, South Africa

Location

Novartis Investigative Site

Busan, Busan, 602-739, South Korea

Location

Novartis Investigative Site

Koyang-si, Gyeonggi-do, 410-773, South Korea

Location

Novartis Investigative Site

Seoul, Seoul, 140-743, South Korea

Location

Novartis Investigative Site

Seoul, 158-710, South Korea

Location

Novartis Investigative Site

Cambridge, United KIngdom, CB7 5JD, United Kingdom

Location

Novartis Investigative Site

Watford, United Kingdom, WD25 0EA, United Kingdom

Location

Novartis Investigative Site

Bath, BA1 2SR, United Kingdom

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Novartis Investigative Site

Bath, BA2 3HT, United Kingdom

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Novartis Investigative Site

Chesterfield, S40 4TF, United Kingdom

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Novartis Investigative Site

Glasgow, G69 7AD, United Kingdom

Location

Novartis Investigative Site

Irvine, KA12 0AY, United Kingdom

Location

Novartis Investigative Site

Lancashire, FY3 7EN, United Kingdom

Location

Novartis Investigative Site

Wellingborough, NN8 4RW, United Kingdom

Location

Related Publications (2)

• Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.

  PMID: 25677679 DERIVED

• Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.

  PMID: 23867808 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination

Condition Hierarchy (Ancestors)

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

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: May 5, 2010
• First Posted: May 11, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 31, 2013
• Results First Posted: January 21, 2013

Record last verified: 2013-01

Locations

IN (9); LI (6); HU (5); RO (5); ZA (2); FR (5); KR (4); CA (4); GB (9); LA (4)