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
Study Type
OBSERVATIONAL
Enrollment
6
Justus-Liebig-University Giessen
Giessen, Germany
Lungenfachklinik Waldhof Elgershausen
Greifenstein, Germany
Philipps-Universität Marburg
Marburg, Germany
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.
Time frame: 38 weeks
Standardized asthma related quality of life questionnaire (AQLQs)
AQLQs will be completed at screening, randomization, crossover and at end of study
Time frame: 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.
Time frame: 38 weeks
Lung function
Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography.
Time frame: 38 weeks
Diffusing capacity for carbon monoxide
Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.
Time frame: 38 weeks
Capillary blood gas analysis
Capillary blood gas analysis will be obtained from the arterialized ear lobe.
Time frame: 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).
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Time frame: 38 weeks
Cell differential in induced sputa
Induced sputum will be obtained at screening if not done within the previous 2 years.
Time frame: 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.
Time frame: 38 weeks