Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Giessen
With
Activaero GmbH
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Inhaled Steroids and Control of Severe Asthma
