A Study to Assess the Long-term Safety of QVA149

Chronic Obstructive Pulmonary Disease Clinical Trial

— ENLIGHTEN  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120717
• Other study ID #: CQVA149A2307
• Secondary ID: 2009-013235-38
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: January 28, 2013
• Start date: April 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: Research Ethics Medical CommitteeHungary: National Institute of PharmacyIndia: Central Drugs Standard Control OrganizationIndia: Drugs Controller General of IndiaKorea: Food and Drug AdministrationKorea: Institutional Review BoardLatvia: State Agency of MedicinesLatvia: Institutional Review BoardLithuania: Bioethics CommitteeLithuania: State Medicine Control Agency - Ministry of HealthRomania: Ministry of Public HealthRomania: National Medicines AgencySouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics CouncilUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 ß2 agonists

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
capsules for inhalation, delivered by an SDDPI
• Placebo
capsules for inhalation, delivered by an SDDPI

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Mirabel	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Québec	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Beuvry
France	Novartis Investigative Site	Ferolles-Attily
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nantes
France	Novartis Investigative Site	Pessac
Hungary	Novartis Investigative Site	Aszod
Hungary	Novartis Investigative Site	Baja
Hungary	Novartis Investigative Site	Erd
Hungary	Novartis Investigative Site	Godollo
Hungary	Novartis Investigative Site	Makó
India	Novartis Investigative Site	Banglaore	Karnataka
India	Novartis Investigative Site	Chennai - Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Dehli	New Delhi
India	Novartis Investigative Site	Indore	Madhya Pradesh
India	Novartis Investigative Site	Mangalore
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	New Delhi	Delhi
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Koyang-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Jekabpils
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga	LV
Lithuania	Novartis Investigative Site	Alytus
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Vilnius
Lithuania	Novartis Investigative Site	Vilnius
Romania	Novartis Investigative Site	Brasov	Jud. Brasov
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 3
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
United Kingdom	Novartis Investigative Site	Bath
United Kingdom	Novartis Investigative Site	Bath
United Kingdom	Novartis Investigative Site	Cambridge
United Kingdom	Novartis Investigative Site	Chesterfield
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Irvine
United Kingdom	Novartis Investigative Site	Lancashire
United Kingdom	Novartis Investigative Site	Watford
United Kingdom	Novartis Investigative Site	Wellingborough

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  France,  Hungary,  India,  Korea, Republic of,  Latvia,  Lithuania,  Romania,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Pre-dose FEV1	Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.	52 weeks	No
Secondary	Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period	Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L	52 weeks	Yes
Secondary	Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period	Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L	52 weeks	Yes
Secondary	Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period	Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.	52 weeks	Yes
Secondary	Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period	Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).	52 weeks	Yes