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Register:	EUCTR
Last refreshed on:	1 May 2012
Main ID:	EUCTR2007-003189-16-IT
Date of registration:	15/11/2007
Prospective Registration:	Yes
Primary sponsor:	NOVARTIS FARMA
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 patients with COPD - ND
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 patients with COPD - ND
Date of first enrolment:	22/01/2008
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
Phase:

Countries of recruitment
France	Germany	Hungary	Ireland	Italy	Latvia	Lithuania	United Kingdom

Contacts

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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.) 2. 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% (Post refers to within 30 min of inhalation of 400/360 µg of salbutamol/albuterol MDI (or equivalent dose of DPI
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 10009026 Term: Chronic obstructive airways disease

Intervention(s)

Trade Name: FORADIL
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Formoterol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 12-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Product Code: QMF149B
Pharmaceutical Form: Inhalation powder, pre-dispensed
Current Sponsor code: QMF149B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 62.5-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Product Code: QMF149B
Pharmaceutical Form: Inhalation powder, pre-dispensed
Current Sponsor code: QMF149B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Product Code: QMF149B
Pharmaceutical Form: Inhalation powder, pre-dispensed
Current Sponsor code: QMF149B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol Twisthaler
Product Code: QMF149B
Pharmaceutical Form: Inhalation powder, pre-dispensed
Current Sponsor code: QMF149B
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
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 (trough) FEV1 after 14 days of treatment.

Secondary Objective: To assess the bronchodilator effect of indacaterol Twisthaler at 62.5, 125, 250, and 500 µg o.d. in patients with COPD compared to placebo as measured by: Mean change from baseline to 24 hr (trough) FEV1 after 1 day of treatment Time to peak FEV1 on Day 1 and Day 14 FEV1 and FVC at each time point post-dose after 1 day and 14 days of treatment Standardized FEV1 AUC between baseline (pre-dose) and 4 hr post-dose on Day 1 and Day 14 To assess Inspiratory Capacity (IC), day and night time rescue medication usage, and morning and evening PEF measurements for indacaterol Twisthaler(62.5, 125, 250, and 500 µg o.d.) in comparison to placebo. To estimate the effects of treatment between formoterol (12 µg b.i.d.) and placebo for all of the efficacy variables above.

Primary end point(s): The goals of the study are to confirm an overall dose-response signal in terms of the mean change from baseline FEV1 to 24 hr post-dose trough FEV1 and, if so, (ii) to estimate the dose that corresponds to the clinically relevant effect. Here, the clinically relevant effect is at least equal to the difference in the mean of primary efficacy variable of formoterol over placebo. The MCP-Mod methodology (Bretz, Pinheiro, and Branson, 2005) will be used to address both of these goals. This document (090095a880c52bb4 in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI. Signatures manifested as of 6/21/2007 9:54:13 AM, signing status at this time: Completed (3 of 3 signatures) Approved for report publication by Lu Yimeng in East Hanover at Wed, 20 Jun 2007 12:58:43 PM EDT Approved for report publication by Cameron Ray in Horsham at Thu, 21 Jun 2007 08:53:17 BST Approved for report publication by Armstrong Linda in East Hanover at Wed, 20 Jun 2007 08:17:34 AM EDT

Secondary Outcome(s)

Secondary ID(s)

CQMF149B2201

2007-003189-16-IE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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