Status:
TERMINATED
Inhaled Steroids and Control of Severe Asthma
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Activaero GmbH
Conditions:
Severe Persistent Asthma
Eligibility:
All Genders
18-80 years
Brief Summary
Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI) Objectives: To explore if inhalative fluticasone application by means of the AKITA technology would result in a b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01197482
Start Date
September 1 2010
End Date
December 28 2018
Last Update
November 10 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Justus-Liebig-University Giessen
Giessen, Germany, 35392
2
Lungenfachklinik Waldhof Elgershausen
Greifenstein, Germany
3
Philipps-Universität Marburg
Marburg, Germany