Inhaled Steroids and Control of Severe Asthma (INHALE)

Inclusion Criteria:

• Severe persistent asthma bronchiale with diagnosis according to the criteria of the Global Initiative for Asthma (GINA) executive summary
• Treatment with at least inhaled corticosteroids (ICS) and long acting b agonists (LABA)
• Evidence of inflammatory triggered form of asthma with at least one of the following:
• sensitization to typical aerogenous allergens
• increased Serum IgE levels
• Eosinophilia in peripheral blood
• Proven Eosinophilia in sputum differential (> 3%) in the previous 2 years
• at least 2 exacerbations of asthma within the previous 24 months leading to unscheduled presentation at a health care provider and/or systemic corticosteroid
• Signed informed consent
• Requirements of the local ethics committee are met

Exclusion Criteria:

• Acute exacerbation of asthma within the last 6 weeks Rtot > 350% predicted capillary pO2 < 60mmHG, pCo2 > 50mmHG near fatal asthma or anaphylaxis in history
• Age ≤ 18 and > 80 years
• Active smoking or > 15 pack-years former smoking
• Oral steroid treatment with a prednisolon-equivalent dose exceeding 10 mg per day
• Pregnancy, nursing females
• Female without use of effective contraceptive method
• Treatment with investigational drugs over the past 30 days or during the course of the trial
• Severe and uncontrolled gastroesophageal reflux disease
• Ongoing psychiatric disorder
• Treatment with systemic corticosteroids for any reason other than asthma
• Other active lung diseases
• Medical history of other uncontrolled diseases 3 months prior randomization (e.g. infections, coronary heart diseases and metabolic diseases)
• Any history of malignancy requiring ongoing treatment and/or limiting life-expectancy
• Clinically significant abnormalities in electrocardiogram (ECG) or laboratory exams
• Asthma related to non-steroidal anti-inflammatory drug (NSAID)
• Insulin dependent diabetes mellitus
• Cataract