Inhaled Steroids and Control of Severe Asthma

Study Overview
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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

Official Title
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Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)

Conditions
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Severe Persistent Asthma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | Changes in asthma control, measured by Juniper Asthma Control Questionnaire during the 16 week treatment period in AKITA versus MDI based steroid application. Physician will assess level of asthma control in accordance with criteria from Gaining Optimal Asthma Control (GOAL) study. | 38 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized asthma related quality of life questionnaire (AQLQs) | AQLQs will be completed at screening, randomization, crossover and at end of study | 38 weeks | 
| Steroid, fluticasone and reliever medication use | doses of systemic steroids and fluticasone dosage will be assessed and documented. Frequency of use of reliever medication will be summed from patient's diary and documented. | 38 weeks | 
| Lung function | Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography. | 38 weeks | 
| Diffusing capacity for carbon monoxide | Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration. | 38 weeks | 
| Capillary blood gas analysis | Capillary blood gas analysis will be obtained from the arterialized ear lobe. | 38 weeks | 
| Measurement of Fractional Concentration of Nitric Oxide in Exhaled Air (feNO) | feNO will be assessed at each visit. Measurements will be performed following the recommendations of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). | 38 weeks | 
| Cell differential in induced sputa | Induced sputum will be obtained at screening if not done within the previous 2 years. | 1 day | 
| Adrenal function | Determination of the fraction of urinary cortisol has been used for screening of adrenal hypo- or hyperfunction and showed to be as effective as 24 hour urinary free cortisol excretion. Urine samples will be obtained at baseline, randomization, crossover and end of study.Values will be recorded. | 38 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, inhalation