A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2007-003189-16-LV
• Date of registration: 22/07/2008
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services AG
• Public title: A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.
• Scientific title: A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.
• Date of first enrolment: 06/11/2007
• Target sample size: 558
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003189-16
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
-Male and female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment – see Section 6.6.5.5.)
-Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:
a) Smoking history of at least 10 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 women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
-Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
-Patients with a history of asthma.
-Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
-Other clinically significant conditions which may interfere with the study conduct or patient safety
as specified in the protocol.


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

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD

Intervention(s)

Product Name: Indacaterol Twisthaler
Pharmaceutical Form: Inhalation powder
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 62.5-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Pharmaceutical Form: Inhalation powder
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Pharmaceutical Form: Inhalation powder
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Pharmaceutical Form: Inhalation powder
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Trade Name: Foradil Aerolizer
Pharmaceutical Form: Inhalation powder, hard capsule
CAS Number: 73573-87-2
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: 125, 250, and 500 µg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose (trough) FEV1 after 14 days of treatment. (Baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before the first study drug administration. Trough FEV1 is defined as the mean of 2 measurements at 23 hr 10 min and 23 hr 45 min post-dose).

Secondary Objective: -Efficacy
To assess the bronchodilator effect of four doses of indacaterol Twisthaler® at 62.5, 125, 250, and 500 µg o.d. in patients with COPD compared to placebo
To estimate the effects of treatment with formoterol (12 µg b.i.d.) and placebo for all of the efficacy variables above
- Safety
To assess the safety of multiple doses of indacaterol Twisthaler® in patients with COPD by comparing four doses (62.5, 125, 250, and 500 µg o.d.) in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs.
To assess the safety of formoterol (12 µg b.i.d) in comparison to placebo, in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECG.

Primary end point(s): Trough FEV1 assessed as mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.

Secondary ID(s)

CQMF149B2201

2007-003189-16-IE