Inhaled Steroids and Control of Severe Asthma (INHALE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01197482|
Recruitment Status : Terminated (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.)
First Posted : September 9, 2010
Last Update Posted : November 10, 2020
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
|Condition or disease|
|Severe Persistent Asthma|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 28, 2018|
|Actual Study Completion Date :||December 28, 2018|
- Asthma control [ Time Frame: 38 weeks ]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.
- Standardized asthma related quality of life questionnaire (AQLQs) [ Time Frame: 38 weeks ]AQLQs will be completed at screening, randomization, crossover and at end of study
- Steroid, fluticasone and reliever medication use [ Time Frame: 38 weeks ]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.
- Lung function [ Time Frame: 38 weeks ]Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography.
- Diffusing capacity for carbon monoxide [ Time Frame: 38 weeks ]Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.
- Capillary blood gas analysis [ Time Frame: 38 weeks ]Capillary blood gas analysis will be obtained from the arterialized ear lobe.
- Measurement of Fractional Concentration of Nitric Oxide in Exhaled Air (feNO) [ Time Frame: 38 weeks ]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).
- Cell differential in induced sputa [ Time Frame: 1 day ]Induced sputum will be obtained at screening if not done within the previous 2 years.
- Adrenal function [ Time Frame: 38 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197482
|Giessen, Germany, 35392|
|Lungenfachklinik Waldhof Elgershausen|
|Principal Investigator:||Andreas Guenther, MD||University of Giessen|