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
- Conditions
- Moderate asthmaMedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
- Registration Number
- EUCTR2007-004377-26-GB
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method