The patients will have mild steroid naïve asthma, that is, patients who suffer from intermitent or persistent mild symptoms of asthma and who have not received inhaled steroids at least within 3 months prior to inclusion. Patients, who are active smokers will be not included in the study, since smoking can affect the values of exhaled NO. Only ex-smokers who have stopped smoking at least 1 year ago will be allowed to participate, if they have a smoking history of less than 10 pack-years. MedDR
Conditions
Interventions
Product Name: Foradil P®
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Formoterolfumarat 2H2O
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration n
Sponsors
Pulmonary Research Institute GmbH an der Asklepiosklinik Barmbek. Niederlassung Hamburg.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patients with intermittent or mild persistent asthma, according to the GINA guidelines2. ·Male or female patients 18 years of age or older. ·FEV1 = 80% of predicted value. ·Increased hyper-responsiveness to methacholine with a PC20FEV1 of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·Pregnant women, nursing mothers or females with childbearing potential, regardless of whether or not they are sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception). ·History of substance abuse or drug abuse within 12 previous months. ·Other respiratory diseases except asthma and allergic rhinitis. ·Use of inhaled within the last 6 weeks or oral/systemic steroids of any kind of corticosteroids in the last 3 months. ·Recent respiratory infection (upper and lower airways) in the last month prior to V0 . ·Asthma exacerbation within 6 weeks prior to inclusion. ·Prophylactic vaccinations against infectious agents within the last 4 weeks. (Flu). ·Treatment with SIT (specific immuntherapy against aeroallergens). ·Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders that may interfere with successful completion of the study. ·Participation in an investigational drug study within 30 days prior to visit 1 or current participation in another investigational drug study. ·Known sensitivity to the study medication or to any of the excipients contained in any of these formulations. ·Patients who take any other medication for their asthma than beta-2-agonists. ·Patients with a stage 2 hypertension or higher, that is, patients with systolic values iqual or greater than 160 mmHg or diastolic values iqual or greater than 100 mmHg ·Non compliant patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will compare the anti-inflammatory effects of inhaled Budesonide when it is administered 5 minutes after the inhalation of Formoterol (sequential treatment) and when it is given together with Formoterol at the same time. Our hypothesis is that the sequential treatment is more effective in reducing the underlying bronchial inflammation as the simultaneous administration of both drugs. The parameter to measure the reduction of the inflammation will be the fractional exhaled nitric oxide, as a sensitive and non invasive inflammation marker. ;Secondary Objective: Secondary endpoints are other parameters which also quantify indirectly the presence of bronchial inflammation, such as: ·The lung function parameters of FEV1 and FVC. ·eNO concentration at visits 2 to 5. ·Number of eosinophils in induced sputum at screening visit 2 and at visit 6. ·PC30 to methacholine. ·The slope of reduction of eNO. ;Primary end point(s): The primary efficacy endpoint is the ratio between the fractional exhaled nitric oxide after 4 treatment days (eNO on visits 5/11) versus the NO concentration at baseline (visit 1/6). | — |
Countries
Germany
Outcome results
None listed