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Inhaled Steroids and Control of Severe Asthma

NCT ID: NCT01197482

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2018-12-28

Brief Summary

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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

Detailed Description

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Conditions

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Severe Persistent Asthma

Keywords

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asthma inhalation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Activaero GmbH

INDUSTRY

Sponsor Role collaborator

University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Carmen Brittinger

KKS Sponsor representative

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Guenther, MD

Role: PRINCIPAL_INVESTIGATOR

University of Giessen

Locations

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Justus-Liebig-University Giessen

Giessen, , Germany

Site Status

Lungenfachklinik Waldhof Elgershausen

Greifenstein, , Germany

Site Status

Philipps-Universität Marburg

Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AZ 109/09

Identifier Type: -

Identifier Source: org_study_id