Clinical trial NCT01120717: A Study to Assess the Long-term Safety of QVA149
Official title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: QVA149
COPD
combination bronchodilator
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 339
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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%

Exclusion Criteria:

* 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
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Adverse Events, Serious Adverse Events or Death
timeFrame: 52 weeks + Follow-up (Up to Day 394)
Secondary outcomes:
measure: Pre-dose FEV1
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
measure: Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Québec
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Beuvry
country: France
facility: Novartis Investigative Site
city: Ferolles-Attily
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Aszod
country: Hungary
facility: Novartis Investigative Site
city: Baja
country: Hungary
facility: Novartis Investigative Site
city: Erd
country: Hungary
facility: Novartis Investigative Site
city: Godollo
country: Hungary
facility: Novartis Investigative Site
city: Makó
country: Hungary
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Banglaore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mysore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Indore
country: India
facility: Novartis Investigative Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Dehli
country: India
facility: Novartis Investigative Site
state: New Delhi
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Chennai - Tamil Nadu
country: India
facility: Novartis Investigative Site
city: Mangalore
country: India
facility: Novartis Investigative Site
city: Koyang-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Jekabpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Alytus
country: Lithuania
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: District 3
city: Brasov
country: Romania
facility: Novartis Investigative Site
state: Jud. Brasov
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud. Iasi
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Irvine
country: United Kingdom
facility: Novartis Investigative Site
city: Lancashire
country: United Kingdom
facility: Novartis Investigative Site
city: Watford
country: United Kingdom
facility: Novartis Investigative Site
city: Wellingborough
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.