TerminatedNot Applicable

Inhaled Steroids and Control of Severe Asthma

Stopped: 6 out of 20 patients were included. The trend towards the treatment of severe asthma has meanwhile developed in a different direction, so that there is no longer any intention to pursue the study objective mentioned here.

Germany6 participantsStarted 2010-09

Plain-language 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 better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional MDI. Study design: open label, cross-over (one AKITA, one MDI arm) Patients: 20 Patients with severe persistent asthma

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hist…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Asthma control

Timeframe: 38 weeks

Trial details

NCT IDNCT01197482

SponsorUniversity of Giessen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-28

View on ClinicalTrials.gov More Severe Persistent Asthma trials