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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00558285




Registration number
NCT00558285
Ethics application status
Date submitted
12/11/2007
Date registered
14/11/2007
Date last updated
30/11/2012

Titles & IDs
Public title
Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
CQVA149A2203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - indacaterol/glycopyrrolate
Treatment: Drugs - indacaterol
Treatment: Drugs - glycopyrrolate
Treatment: Drugs - placebo

Experimental: indacaterol/glycopyrrolate 600/100 µg - Two capsules indacaterol/glycopyrrolate 300/50 µg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Experimental: indacaterol/glycopyrrolate 300/100 µg - One capsule indacaterol/glycopyrrolate 300/100 µg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Experimental: indacaterol/glycopyrrolate 150/100 µg - One capsule indacaterol/glycopyrrolate 150/50 µg and one capsule 50 µg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Active comparator: indacaterol 300 µg - One capsule indacaterol 300 µg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Placebo comparator: placebo - Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.


Treatment: Drugs: indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Treatment: Drugs: indacaterol
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Treatment: Drugs: glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

Treatment: Drugs: placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Mean 24 Hour Heart Rate at Day 14
Timepoint [1] 0 0
Baseline, Day 14
Secondary outcome [1] 0 0
Change From Baseline in Mean 24 Hour Heart Rate at Day 1
Timepoint [1] 0 0
Baseline, Day 1
Secondary outcome [2] 0 0
Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14
Timepoint [2] 0 0
Day 1, Day 14
Secondary outcome [3] 0 0
Trough Forced Vital Capacity (FVC) at Day 1 and Day 14
Timepoint [3] 0 0
Day 1 and Day 14
Secondary outcome [4] 0 0
Change From Baseline in QTc (Fridericia's Formula) at Day 1
Timepoint [4] 0 0
Baseline, Day 1
Secondary outcome [5] 0 0
Change From Baseline in QTc (Fridericia's Formula) at Day 7
Timepoint [5] 0 0
Baseline, Day 7
Secondary outcome [6] 0 0
Change From Baseline in QTc (Fridericia's Formula) at Day 14
Timepoint [6] 0 0
Baseline, Day 14

Eligibility
Key inclusion criteria
* Consented male or female adults aged =40 years
* Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
* Patients who have 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/Forced vital capacity (FVC) <0.70 at Visit 1 and Visit 3
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or nursing (lactating) women
* Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
* Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
* Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
* Any history of asthma
* Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation [AF]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
* Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
* Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (>450 ms for males or >470 for females)
* History of malignancy of any organ system, treated or untreated within the past 5 years
* Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) >8.0% of total hemoglobin measured at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigator Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigator Site - Clayton
Recruitment hospital [3] 0 0
Novartis Investigator Site - Daw Park
Recruitment hospital [4] 0 0
Novartis Investigator site - Heidelberg
Recruitment hospital [5] 0 0
Novartis Investigator Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Jambes
Country [3] 0 0
Belgium
State/province [3] 0 0
Jette
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Belgium
State/province [5] 0 0
Oostende
Country [6] 0 0
Canada
State/province [6] 0 0
Mississauga
Country [7] 0 0
Canada
State/province [7] 0 0
Newmarket
Country [8] 0 0
Canada
State/province [8] 0 0
Ottawa
Country [9] 0 0
Canada
State/province [9] 0 0
Pointe-Claire
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Canada
State/province [11] 0 0
Sainte-Foy
Country [12] 0 0
France
State/province [12] 0 0
Ambroise
Country [13] 0 0
France
State/province [13] 0 0
Lille
Country [14] 0 0
France
State/province [14] 0 0
Marseille
Country [15] 0 0
France
State/province [15] 0 0
Martigues
Country [16] 0 0
France
State/province [16] 0 0
Nantes
Country [17] 0 0
France
State/province [17] 0 0
Nice
Country [18] 0 0
France
State/province [18] 0 0
Perpignan
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Dortmund
Country [21] 0 0
Germany
State/province [21] 0 0
Erfurt
Country [22] 0 0
Germany
State/province [22] 0 0
Hannover
Country [23] 0 0
Germany
State/province [23] 0 0
Mainz
Country [24] 0 0
Germany
State/province [24] 0 0
Marburg
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
Modena
Country [27] 0 0
Italy
State/province [27] 0 0
Trieste
Country [28] 0 0
Spain
State/province [28] 0 0
Badalona
Country [29] 0 0
Spain
State/province [29] 0 0
Baracaldo
Country [30] 0 0
Spain
State/province [30] 0 0
Caceres
Country [31] 0 0
Spain
State/province [31] 0 0
Centelles
Country [32] 0 0
Spain
State/province [32] 0 0
Mataro
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
Turkey
State/province [34] 0 0
Istanbul
Country [35] 0 0
Turkey
State/province [35] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharma AG
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00558285