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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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1 May 2012 |
Main ID: |
EUCTR2007-003189-16-LT |
Date of registration:
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04/10/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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:
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06/12/2007 |
Target sample size:
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558 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003189-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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France
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Germany
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Hungary
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Ireland
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Italy
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Latvia
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Lithuania
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1
Level: LLT
Classification code 10010952
Term: COPD
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Intervention(s)
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Product Name: Indacaterol Twisthaler Pharmaceutical Form: Inhalation powder INN or Proposed INN: Indacaterol 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 INN or Proposed INN: Indacaterol 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 INN or Proposed INN: Indacaterol 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 INN or Proposed INN: Indacaterol 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 INN or Proposed INN: Formoterol 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
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Primary Outcome(s)
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Primary end point(s): Trough FEV1 assessed as mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.
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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.
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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).
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Secondary ID(s)
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2007-003189-16-IE
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CQMF149B2201
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Source(s) of Monetary Support
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Results
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Results available:
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