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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. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-002195-15-GB |
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Date of registration:
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15/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EVALUATION OF THE 24-HOUR TROUGH FEV1 FOLLOWING 7 DAYS OF DOSING WITH CHF4226 2µg ONCE DAILY.
A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL GROUP, PLACEBO AND ACTIVE (FORMOTEROL 12µg B.I.D.) CONTROLLED STUDY FOLLOWED BY A 3-WEEK OPEN LABEL EXTENSION (TO EITHER CHF4226 2µg Q.D. OR FORMOTEROL 12µg B.I.D. IN A 2:1 RATIO) FOR THE EVALUATION OF SAFETY AND TOLERABILITY
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Scientific title:
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EVALUATION OF THE 24-HOUR TROUGH FEV1 FOLLOWING 7 DAYS OF DOSING WITH CHF4226 2µg ONCE DAILY.
A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PARALLEL GROUP, PLACEBO AND ACTIVE (FORMOTEROL 12µg B.I.D.) CONTROLLED STUDY FOLLOWED BY A 3-WEEK OPEN LABEL EXTENSION (TO EITHER CHF4226 2µg Q.D. OR FORMOTEROL 12µg B.I.D. IN A 2:1 RATIO) FOR THE EVALUATION OF SAFETY AND TOLERABILITY
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Date of first enrolment:
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11/08/2005 |
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Target sample size:
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180 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002195-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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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: yes
Other trial design description: double-dummy
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
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Countries of recruitment
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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:
- Written informed consent obtained
- Male or female patients aged 18 years and over
- Moderate or severe persistent asthma according to the GINA 2004 “Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment”
- Patients free of long-acting ?b2 agonists treatment (LABAs) at least for 4 weeks before the screening visit and already treated for at least 1 month with inhaled corticosteroids at a stable dose corresponding to mild-medium asthma severity (GINA 2004)
- Asthma not adequately controlled on existing therapy, defined as presence of daytime asthma symptoms > once a week and night time asthma symptoms > twice a month, and frequent use of short-acting ß2-agonists. These findings are to be based on recent medical history and are to be confirmed at the end of the run-in period
- Forced expiratory volume in the first second (FEV1) less or equal to 90% of predicted for the patient normal value and not less than 0.9 L in absolute value
- Positive response to the reversibility test in the screening visit, defined as an increase of at least 15% and at least 200 mL from pre-dosing value in the measurement of FEV1 30 minutes following 2 puffs (2 x 100 µg) of inhaled salbutamol pMDI)
- Non-smokers or ex-smokers < 5 pack-year [e.g. less than 1 pack cigarettes (i.e. 20 cigarettes) per day for 5 years or 2 packs cigarettes per day for 2.5 years] and having stopped smoking > 1 year
- A co-operative attitude and ability to be trained to correctly use the pMDI and the Aerolizer inhaler
- At the end of the run-in period, the presence of day-time asthma symptoms (of at least mild intensity) > once a week and night time asthma symptom (of at least mild intensity) > twice a month, as well as of frequent use of relief salbutamol is to be confirmed by means of patient interview by the investigator.
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:
- Inability to carry out pulmonary function testing
- Diagnosis of COPD as defined by the current GOLD guidelines
- Current smoker or ex-smoker with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start
- History of near fatal asthma
- History of significant seasonal variation of asthma
- Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake)
- Hospitalisation due to asthma during the previous 8 weeks
- Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 3 months
- Patients treated with short-acting ß2-agonists in the past 8 hours, short-acting anticholinergics in the past 12 hours, long-acting anticholinergics (i.e. tiotropium bromide) in the past 48 hours, leukotriene antagonists in the past 2 weeks
- Patients treated with oral or nebulised bronchodilators in the 4 weeks prior to study start
- Patients treated with nebulised corticosteroids in the 4 weeks prior to study start
- Patients who have changed their dose or formulation of inhaled or nasal corticosteroids during the previous 4 weeks
- Patients treated with a xanthine derivative (e.g. theophylline) any formulation in the 4 weeks prior to study start
- Patients treated with sodium cromoglycate or nedocromil sodium in the 4 weeks prior to study start
- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiac disease
- Patients with a QTc interval (Bazett’s formula) in the ECG test > 450 msec in males or > 470 msec in females
- Uncontrolled diabetes mellitus
- Serum potassium < 3.5 Meq/L or > 6.0mEq/L
- Clinically significant or unstable concurrent disease, e.g. uncontrolled hyperthyroidism, significant hepatic impairment, significant pulmonary disease other than asthma (e.g. tuberculosis, lung cancer), gastrointestinal disease (e.g. active peptic ulcer), neurological or haematological autoimmune disorders
- Cancer or any other chronic disease with poor prognosis and /or affecting patient status
- Pregnant or lactating females or females at risk of pregnancy (those not making use of an effective contraceptive method). A pregnancy test will be performed at screening in women of childbearing potential
- History of alcohol or drug abuse
- Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants, SSRI, or beta-blockers
- Patients treated with terfenadine or astemizole
- Patients having started treatment with other antihistamines less than 2 weeks prior to the screening visit or for whom the dosage can not be kept constant throughout the study.
- Allergy, sensitivity or intolerance to beta2-aderenergic agonists and/or study drug formulation ingredients
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Persistent asthma
MedDRA version: 7.0
Level: Low
Classification code 10003553
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Intervention(s)
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Product Name: CHF 4226 pMDI
Product Code: CHF4226
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: carmoterol
Current Sponsor code: CHF 4226
Other descriptive name: TA-2005
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Pressurised inhalation, solution
Route of administration of the placebo: Inhalation use
Trade Name: FORADIL 12 µg poudre pour inhalation
Product Name: FORADIL 12 µg poudre pour inhalation
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Formoterol Fumarate
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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Main Objective: To characterise the mean trough 23-24 hrs FEV1 following 7 days of dosing of CHF 4226 2µg given o.d. and to compare it with placebo.
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Secondary Objective: - After 7 days of dosing:
. to compare the mean through 23-24h FEV1 observed with CHF 4226 2µg o.d. with the one following first administration of CHF 4226 2 µg o.d.
. to compare the mean through of FEV1 observed: CHF 4226 with Formoterol 12 µg b.i.d.‚ Formoterol 12µg b.i.d. with placebo
. to compare the FEV1 at 1h, 2h and 3h post morning dose administration observed: CHF 4226 with placebo and formoterol
- After 1 day of dosing:
to compare the mean trough 23-24h FEV1 observed: CHF 4226 with placebo‚ Formoterol with placebo, CHF 4226 with Formoterol.
- To monitor for safety and tolerability.
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Primary end point(s): -Trough FEV1 (L) (mean of 23 and 24 hours) at Day 8 after 7 days of dosing.
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Secondary ID(s)
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RA/PR/033009/004/04
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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