Clinical trial NCT01197482: Inhaled Steroids and Control of Severe Asthma
Official title: Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Persistent Asthma
Keywords: asthma
inhalation
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Activaero GmbH
First posted: 2010-09-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe persistent asthma

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Asthma control
timeFrame: 38 weeks
Secondary outcomes:
measure: Standardized asthma related quality of life questionnaire (AQLQs)
timeFrame: 38 weeks
measure: Steroid, fluticasone and reliever medication use
timeFrame: 38 weeks
measure: Lung function
timeFrame: 38 weeks
measure: Diffusing capacity for carbon monoxide
timeFrame: 38 weeks
measure: Capillary blood gas analysis
timeFrame: 38 weeks
measure: Measurement of Fractional Concentration of Nitric Oxide in Exhaled Air (feNO)
timeFrame: 38 weeks
measure: Cell differential in induced sputa
timeFrame: 1 day
measure: Adrenal function
timeFrame: 38 weeks
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Justus-Liebig-University Giessen
city: Greifenstein
country: Germany
facility: Lungenfachklinik Waldhof Elgershausen
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
Study officials:
affiliation: University of Giessen
name: Andreas Guenther, MD
role: PRINCIPAL_INVESTIGATOR
References: