EUCTR2007-004377-26-GBActive, not recruitingPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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;
Investigators
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