Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00615459




Registration number
NCT00615459
Ethics application status
Date submitted
1/02/2008
Date registered
14/02/2008
Date last updated
17/08/2011

Titles & IDs
Public title
A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Scientific title
A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 µg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 µg o.d.) as an Active Control
Secondary ID [1] 0 0
CQAB149B2331
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
Treatment: Drugs - Tiotropium
Treatment: Drugs - Placebo

Experimental: Sequence 1: Placebo,Tiotropium, Indacaterol 150 µg - In period I, placebo to indacaterol (150 or 300 µg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 µg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 µg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) ß2-agonist (SABA) was available for rescue use throughout the study.

Experimental: Sequence 2: Indacaterol 300 µg, Indacaterol 150 µg, Tiotropium - In period I,indacaterol 300 µg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 µg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 µg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

Experimental: Sequence 3: Indacaterol 150 µg, Indacaterol 300 µg, Placebo - In period I, indacaterol 150 µg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 µg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 µg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

Experimental: Sequence 4: Tiotropium, Placebo, Indacaterol 300 µg - In period I, tiotropium (18 µg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 µg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 µg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.


Treatment: Drugs: Indacaterol
Indacaterol 150 µg or 300 µg, delivered via SDDPI

Treatment: Drugs: Tiotropium
Tiotropium 18 µg once daily delivered via inhalation device

Treatment: Drugs: Placebo
Placebo to indacaterol (150 or 300 µg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24-hour Post-dose Trough Forced Expiratory Volume in 1 Second (FEV1) After 14 Days of Treatment
Timepoint [1] 0 0
23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 15 of each treatment period
Secondary outcome [1] 0 0
Peak FEV1 During 4 Hours Post Morning Dose on Day 1
Timepoint [1] 0 0
Day 1 (from 0 to 4 hours post morning dose)

Eligibility
Key inclusion criteria
* Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:

1. Smoking history of at least 10 pack years (current or previous smokers)
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and =30% of the predicted normal value.
3. Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long-term oxygen therapy for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit
* 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 Visit 1 or randomization 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, MDI or perform spirometry measurements

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
Crossover
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
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative site - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Gauting
Country [2] 0 0
Germany
State/province [2] 0 0
Grosshansdorf
Country [3] 0 0
Germany
State/province [3] 0 0
Mainz
Country [4] 0 0
Germany
State/province [4] 0 0
Marburg
Country [5] 0 0
Germany
State/province [5] 0 0
Wiesbaden
Country [6] 0 0
Netherlands
State/province [6] 0 0
Almelo
Country [7] 0 0
Netherlands
State/province [7] 0 0
Breda
Country [8] 0 0
Netherlands
State/province [8] 0 0
Eindhoven
Country [9] 0 0
Netherlands
State/province [9] 0 0
Harderwijk
Country [10] 0 0
Netherlands
State/province [10] 0 0
Helmond
Country [11] 0 0
New Zealand
State/province [11] 0 0
Wellington
Country [12] 0 0
Poland
State/province [12] 0 0
Katowice
Country [13] 0 0
Poland
State/province [13] 0 0
Warsaw
Country [14] 0 0
South Africa
State/province [14] 0 0
Durban
Country [15] 0 0
Spain
State/province [15] 0 0
Alicante
Country [16] 0 0
Spain
State/province [16] 0 0
Cacenes
Country [17] 0 0
Spain
State/province [17] 0 0
La Coruna
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid
Country [19] 0 0
Spain
State/province [19] 0 0
Orense

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
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/NCT00615459