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Main
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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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10 December 2019 |
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Main ID: |
EUCTR2007-004377-26-GB |
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Date of registration:
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07/03/2008 |
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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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Effect of fixed combination of beclomethasone dipropionate/formoterol fumarate (BDP/FF), as reliever, upon exhaled nitric oxide in asthma. FENOMENO study (Fractional Exhaled Nitric Oxide-Multiple Expiration flow of NO). A single-centre, placebo controlled, randomized, double blind, cross-over study - Fenomeno
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Scientific title:
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Effect of fixed combination of beclomethasone dipropionate/formoterol fumarate (BDP/FF), as reliever, upon exhaled nitric oxide in asthma. FENOMENO study (Fractional Exhaled Nitric Oxide-Multiple Expiration flow of NO). A single-centre, placebo controlled, randomized, double blind, cross-over study - Fenomeno |
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Date of first enrolment:
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04/12/2008 |
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Target sample size:
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20 |
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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:2007-004377-26 |
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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: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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:
Patients will be enrolled at Visit 0 into the run-in period if they meet all of the following criteria:
1. Written informed consent obtained
2. Asthmatic patients with asthma according to GINA 2006 on dose of ICS > 500 µg CFC BDP (or Extrafine HFA BDP > 200) or equivalent
3. Out patients of both sexes, aged 30-70
4. A documented positive response to the reversibility test, defined as an improvement in FEV1 of at least 12% from baseline value and/or 200 ml 30 minutes after 4 puffs of inhaled salbutamol pMDI (400 µg) at screening or within a year prior to screening
5. Use of reliever medication (puffs/week) = 5 inhalations/ week as reliever during the last 7 days
6. FENO at the end of the run-in > 25 ppb
7. Skin prick test (test acceptable if done within the past two years)
8. Non smokers
At the end of the run in period the following additional criteria will need to be checked in order to allow the subject to be enrolled in the visit 1:
9. FENO at the end of the run-in > 25 ppb
10. Reliever use: = 5 inhalations/ week during the run in period but less than 8/day
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:
Patients will not be enrolled at visit 0 into the run-in period if they meet one or more of the following criteria:
1. Inability to carry out pulmonary function testing and FENO testing;
2. Diagnosis of COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines updated 2006;
3. Subject on treatment with oral corticosteroids
4. Asthmatic who had hospitalization due to asthma exacerbation or have been prescribed dose of Oral, Intra-Venous or Intra-muscular corticosteroids within the past 4 months
5. Chest infection that required treatment with antibiotics within the last 4 weeks before screening visit;
6. Smoker or ex smoker having a smoking history equal to or greater than 10 pack-years;
7. Any history of clinically significant cardiovascular abnormality;
8. Subjects who have participated in a clinical trial involving an experimental medication in the previous 3 months;
9. Subjects with a history of significant drug or alcohol abuse as judged by the investigator/study physician;
10. Subjects at risk of non-compliance;
11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test (> 5 IU/ml)
12. Women of child-bearing potential may participate in the study if they are taking adequate methods of contraception (surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
13. Subjects who are in need of receiving any not allowed concomitant medication during the study period;
14. Intolerance or contra-indication to treatment with ?2-agonists and/or inhaled corticosteroids;
15. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency;
16. History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit);
17. Diagnosis of restrictive lung disease
18. Subjects currently receiving beta blocker medications (including eye drops) and non-potassium sparing diuretics;
19. Subjects currently receiving any drug that may cause QTc prolongation (e.g. anti-arrhythmics, antidepressants, antihistamines) unless already taken at stable doses for at least 4 weeks prior to screening visit;
20. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion;
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Moderate asthma
MedDRA version: 9.1
Level: LLT
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
CAS Number: 43229-80-7
Other descriptive name: FF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 6-
INN or Proposed INN: Beclomethasone Diproprionate
CAS Number: 5534-09-8
Other descriptive name: BDP
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: Ventolin
Product Name: Salbutamol
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: SALBUTAMOL SULFATE
CAS Number: 51022-70-9
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): FENO on last visit of each treatment period (mean of 2 measurements done with NIOX FLEX).
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Secondary Objective: to further characterize such anti-inflammatory effect on:
• Multiple expiration flow of exhaled NO (MEFENO) exchange parameters: airway wall NO flux, (JNO), and the steady-state alveolar NO concentration (Calv)
• Lung function parameters (spirometry at clinic): FEV1, FVC, PEF, FEF25-75%
• Inflammation biomarkers in sputum.
• Asthma symptoms and use of reliever medication
• Asthma Control based to Juniper Questionnaire
• Safety and Tolerability
In addition, exhaled volatile organic compounds will be measured
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Main Objective: To evaluate in asthmatic patients treated with CHF1535 maintenance therapy the effects of inhaled CHF1535 or salbutamol as reliever medications on airway inflammation as reflected by fractional exhaled NO (FENO) measured after a 28-days treatment period.
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Secondary ID(s)
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FB/PS/14/172/07
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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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