Clinical efficacy of different inhalation sequences of Formoterol and Budesonide in asthmatic patients

• Conditions: 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.; MedDRA version: 8.1Level: LLTClassification code 10003555Term: Asthma bronchial

• Registration Number: EUCTR2005-002462-11-DE
• Lead Sponsor: Pulmonary Research Institute GmbH an der Asklepiosklinik Barmbek. Niederlassung Hamburg.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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 <4 mg/mL and a PC30FEV1 that leads to a 30% decrease in FEV1 after receiving a maximal concentration of 16 mg/ml methacholine.
·One reversibility test with Salbutamol after a dose of 400 µg = 12% increase FEV1 compared to baseline iwithin the last two years.
·Exhaled NO concentration above 40 ppb.
·Ability to produce sputum after inhalation of hypertonic saline.
.Non smoker or ex-smoker with a smoking history of less than 10 pack-years and who have stopped smoking at least 1 year ago.
·Understanding of the study and agreement to give written informed consent before the first study visit.

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) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified