A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 µg b.i.d.) as an active control.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002376-34-DK
• Date of registration: 09/10/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 µg b.i.d.) as an active control.
• Scientific title: A 26-week treatment, multi center, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol (50 µg b.i.d.) as an active control.
• Date of first enrolment: 27/11/2007
• Target sample size: 972
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002376-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Finland, France, Hungary, Iceland, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Male and female adults aged = 40 years, who have signed an Informed Consent .
Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and including:
a) Smoking history of at least 20 pack years
b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
c) Post-bronchodilator FEV1/FVC < 70%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Pregnant or nursing (lactating) women, or women of child-bearing potential UNLESS post-menopausal or using acceptable methods of contraception.
Patients who have had a respiratory tract infection, or hospitalization for a COPD exacerbation, in the 6 weeks prior to Visit 1 or during the run-in period.
Patients requiring oxygen therapy for chronic hypoxemia (>15 h per day delivered by home oxygen cylinder or concentrator).
Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis.
Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3 or onset of respiratory symptoms prior to age 40 years.
Patients with diabetes Type I or uncontrolled diabetes Type II.
Patients who have a clinically relevant laboratory abnormality or a clinically significant condition, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
Any patient with lung cancer or a history of lung cancer; or any patient with active cancer or a history of cancer with less than 5 years disease free survival time on a case-by-case basis.
Patients with a history (or family history) of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged: > 450 ms (males) or > 470 ms (females).
Patients who do not maintain regular day/night, waking/sleeping cycles.
Patients who have had treatment with investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
Some treatments for COPD and allied conditions, or some non-COPD medications, within at the minimum washout period specified or at any time during the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

chronic obstructive pulmonary disease
MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD

Intervention(s)

Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Trade Name: Serevent Accuhaler
Pharmaceutical Form: Inhalation powder
CAS Number: 89365-50-4
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): Trough FEV1 after 12 weeks treatment

Main Objective: To assess indacaterol (150 µg) superiority in patients with COPD as compared to placebo with respect to 24 h post dose trough FEV1 after 12 weeks of treatment.

Secondary Objective: To evaluate the effect of indacaterol on the percentage of “days of poor control”.
To evaluate the effect of indacaterol health related quality of life assessments
To evaluate the effect of indacaterol on exacerbation
To evaluate the effect of indacaterol on the TDI focal score
To compare indacaterol to placebo spirometry assessments in terms of trough FEV1 , FEV1, FVC, peak response, trough response, standardized AUC for FEV1 (5 min – 1h, 5 min – 4h for a sub group)
To evaluate the effect of indacaterol (150 µg o.d.) and placebo on other clinical variables such as morning (pre-medication) and evening (pre-medication) PEF, clinical symptoms and use of rescue medication
To assess the long term safety of indacaterol

Secondary ID(s)

2007-002376-34-IT

CQAB149B2336