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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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19 March 2012 |
Main ID: |
EUCTR2006-005557-30-DE |
Date of registration:
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12/12/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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In-vivo deposition measurement of formoterol and beclomethasone after inhalation of a single dose of the combination Formoterol plus BDP HFA pMDI (Foster®, Chiesi) in healthy volunteers, asthmatic and COPD patients
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Scientific title:
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In-vivo deposition measurement of formoterol and beclomethasone after inhalation of a single dose of the combination Formoterol plus BDP HFA pMDI (Foster®, Chiesi) in healthy volunteers, asthmatic and COPD patients |
Date of first enrolment:
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16/03/2007 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005557-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy subjects: 1. Age 21 - 70 2. Ability to properly use the pMDI 3. Body Mass Index (BMI) between 18.0 and 30 kg/m2 4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine DBP 50-90 mmHg, heart rate 50-90 bpm) 5. Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms). 6. Non-smokers or ex-smokers with a smoking history of less than 5 pack- years and stopped smoking at least one year ago. 7. written informed consent
Patients with Asthma: 1. Age 21 - 70 2. Ability to properly use the pMDI 3. Body Mass Index (BMI) between 18.0 and 30 kg/m2 4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine DBP 50-90 mmHg, heart rate 50-90 bpm). 5. Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms). 6. Patients with moderate persistent or severe persistent Asthma according to the GINA Classification of Asthma Severity by Daily Medication Regimen and Response to Treatment. 7. FEV1 = 30% and < 80% of predicted for the patient’s normal value (according to the predicted value for spirometric function, European Coal and Steel Community values) measured at least 8 hours after the last use of short-acting ß2-agonist bronchodilators or short-acting anticholinergics, 72 hours after the last use of long-acting ß2- agonist bronchodilators and 72 hours after the last use of long-acting anticholinergics. 8. Reversibility of FEV1 = 12% and at least 200 ml of the initial value 30 minutes after inhalation of 200 mcg Salbutamol within the screening period 9. In good health on the basis of a medical history, physical examination, clinical laboratory studies and ECG with the exception of Asthma 10. Non-smokers or ex-smokers with a smoking history of less than 5 pack- years (e.g. < 20 cigarettes per day for 5 years or 40 cigarettes per day for 2.5 years) and stopped smoking at least 1 year ago. 11. written informed consent
Patients with COPD: 1. Age 40 - 70 2. Ability to properly use the pMDI 3. Body weight resulting in a Body Mass Index (BMI) between 18.0 and 30 kg/m2 4. Normal blood pressure and heart rate (supine SBP 100-150 mmHg, supine DBP 50- 90 mmHg, heart rate 50-90 bpm). 5. Electrocardiogram (12 lead) with computerized protocol interpretation considered as normal (120 ms=PR=220ms, QRS=120ms, QTc=450ms). 6. Stable COPD 7. Decreased FEV1 between 30% and 50% predicted values (30% =FEV1 < 50%) measured at least 8 hours after the last use of short-acting ß2- agonist bronchodilators or short-acting anticholinergics, 72 hours after the last use of long-acting ß2-agonist bronchodilators and 72 hours after the last use of long-acting anticholinergics. 8. FEV1/Forced Vital Capacity (FEV1/FVC) = 70% documented at screening visit 9. Reversibility of FEV1 < 12 % of the initial value 30 minutes after inhalation of 200µg Salbutamol within the screening period 10. Treatment with any COPD medication at a constant dosage during the last
Exclusion criteria: All subjects: 1. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before the first intake of study drug 2. Positive HIV1 or HIV2 serology 3. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C 4. Unsuitable veins for repeated venipuncture 5. Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception 6. History of substance abuse or drug abuse within 12 months or with a positive urine drug screen 7. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation 8. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol 9. Participation in an investigational drug study within 30 days prior to Visit 1 or current participation in another investigational drug study 10. Known sensitivity to Formoterol or Beclomethasone or any of the excipients contained in any of the formulations used in the trial. 11. Concomitant severe diseases or diseases which are contra indications for the use of inhaled ?2-agonist or steroids. 12. Use of any prescription drug for which concomitant beta-agonist or steroid administration are contraindicated. 13. History of significant sensitivity, allergy or intolerance to study drug formulation ingredients. 14. Recent relevant infectious disease (less than two months) 15. Flu vaccination within 4 weeks prior to the screening visit 16. Other vaccination within 4 weeks prior to the screening visit
Additional exclusion criteria for patients with Asthma: 1. Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months 2. Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days 3. Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceeding 2l/min, at night time only and/or only during exercise is allowed 4. Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit 5. Asthma exacerbation within the 4 weeks prior to inclusion
Additional exclusion criteria for patients with COPD: 1. Use of systemic steroids 4 weeks prior to inclusion (injectable depot steroids 6 weeks) or more than 3 periods during the last 6 months 2. Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days 3. Requirement of continuous supplemental oxygen therapy; the use of supplemental oxygen not exceeding 2l/min, at night time only and/or only during exercise is allowed 4. Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit 5. COPD exacerbation within the 4 weeks prior to inclusion 6. History of asthma or any ch
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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The study is focused on asthma bronchiale and chronic obstructive pulmonary disease (COPD) MedDRA version: 8.1
Level: PT
Classification code 10003553
Term: Asthma
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Intervention(s)
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Trade Name: Foster Product Name: Foster Product Code: CHF 1535 HFA pMDI Pharmaceutical Form: Pressurised inhalation, solution INN or Proposed INN: Formoterol Fumarate Other descriptive name: FF Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 6- INN or Proposed INN: Beclomethasone Dipropionate Other descriptive name: BDP Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Pressurised inhalation, solution Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Secondary Objective: Secondary objective is to describe intrapulmonary distribution, pharmacokinetic properties of the drug formulation and evaluation of the lung function.
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Primary end point(s): Intrapulmonary deposition
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Main Objective: The aim of the study is to assess intrapulmonary deposition of Foster.
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Secondary ID(s)
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FB/PS/14/165/06
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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