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

• Register: EUCTR
• Last refreshed on: 12 June 2012
• Main ID: EUCTR2007-003191-19-GB
• Date of registration: 11/10/2007
• Prospective Registration: Yes
• 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 of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthma
• Scientific title: A randomized, multi-center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in adult and adolescent patients with persistent asthma
• Date of first enrolment: 31/10/2007
• Target sample size: 488
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003191-19
• 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

Czech Republic, Germany, Hungary, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male and female adult and adolescent patients aged 12-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient’s parent / guardian.
2. Patients with asthma, diagnosed according to GINA guidelines (2006)
Are the trial subjects under 18? yes
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 a reliable form of contraception.
-Patients with asthma, or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
-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

persistent asthma
MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

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
CAS Number: 73573-87-2
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Main Objective: To evaluate the dose response relationship among four doses of indacaterol Twisthaler® (62.5, 125, 250, and 500 µg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose of (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 four doses of indacaterol Twisthaler® in patients with persistent asthma compared to placebo
• Morning and evening PEF measurements for indacaterol Twisthaler® in comparison to placebo.
• To assess day and night time rescue medication usage for indacaterol Twisthaler® in comparison to placebo.
• To estimate the effects of treatment between formoterol and placebo for all of the efficacy variables above
Safety
• To assess the safety of multiple doses of indacaterol Twisthaler® in patients with
persistent asthma by comparing four doses in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs and ECGs.
• To assess the safety of formoterol in patients with persistent asthma in comparison to placebo in terms of the number and percentage of adverse events,
laboratory analysis, vital signs and ECGs.

Primary end point(s): The primary endpoint is trough FEV1, specificallu the mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.

Secondary ID(s)

2007-003191-19-CZ

CQMF149A2201