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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00792805




Registration number
NCT00792805
Ethics application status
Date submitted
17/11/2008
Date registered
18/11/2008
Date last updated
17/08/2011

Titles & IDs
Public title
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Phase III, 26-week Multicenter Randomized Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
CQAB149B2333
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 150 µg
Treatment: Drugs - Indacaterol 300 µg
Treatment: Drugs - Placebo to indacaterol

Experimental: Indacaterol 150 µg - Patients inhaled indacaterol 150 µg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting ß2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Experimental: Indacaterol 300 µg - Patients inhaled indacaterol 300 µg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting ß2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Placebo Comparator: Placebo to indacaterol - Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting ß2-agonist salbutamol/albuterol was available for rescue use throughout the study.


Treatment: Drugs: Indacaterol 150 µg
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Treatment: Drugs: Indacaterol 300 µg
Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Treatment: Drugs: Placebo to indacaterol
Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 - FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.
Timepoint [1] 0 0
Week 12 + 1 day, Day 85

Eligibility
Key inclusion criteria
- Adults aged = 40 years

- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as
classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Guidelines, 2007) and:

1. Smoking history of at least 10 pack years

2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and = 30%
of the predicted normal value

3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have received systemic corticosteroids for a COPD exacerbation in the 6
weeks prior to screening or during the run-in period

- Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia

- Patients who have had a respiratory tract infection within 6 weeks prior to screening

- Patients with concomitant pulmonary disease

- Patients with a history of asthma

- Patients with diabetes Type I or uncontrolled diabetes Type II

- Any patient with lung cancer or a history of lung cancer

- Any patient with active cancer or a history of cancer with less than 5 years
disease-free survival time

- Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured
at screening is prolonged

- Patients who have been vaccinated with live attenuated vaccines within 30 days prior
to screening or during the run-in period

- Patients unable to successfully use a dry powder inhaler device or perform spirometry
measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [3] 0 0
Novartis Investigative Site - Daw Park
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Daw Park
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Changsha
Country [3] 0 0
China
State/province [3] 0 0
Chongqing
Country [4] 0 0
China
State/province [4] 0 0
Fuzhou
Country [5] 0 0
China
State/province [5] 0 0
Guang Zhou
Country [6] 0 0
China
State/province [6] 0 0
Shandong
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
China
State/province [8] 0 0
Shenyang
Country [9] 0 0
China
State/province [9] 0 0
Shijiazhuang
Country [10] 0 0
China
State/province [10] 0 0
Xi'an
Country [11] 0 0
India
State/province [11] 0 0
Bangalore
Country [12] 0 0
India
State/province [12] 0 0
Trivandrum

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

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or
over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
Trial website
https://clinicaltrials.gov/show/NCT00792805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
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

Summary results
Other publications