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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. 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
Activaero GmbH
Information provided by (Responsible Party):
Carmen Brittinger, Philipps University Marburg Medical Center

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

Condition or disease
Severe Persistent Asthma

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Capillary blood gas analysis [ Time Frame: 38 weeks ]
    Capillary blood gas analysis will be obtained from the arterialized ear lobe.

  6. 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).

  7. Cell differential in induced sputa [ Time Frame: 1 day ]
    Induced sputum will be obtained at screening if not done within the previous 2 years.

  8. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe persistent asthma

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01197482

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Justus-Liebig-University Giessen
Giessen, Germany, 35392
Lungenfachklinik Waldhof Elgershausen
Greifenstein, Germany
Philipps-Universität Marburg
Marburg, Germany
Sponsors and Collaborators
University of Giessen
Activaero GmbH
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Principal Investigator: Andreas Guenther, MD University of Giessen
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Responsible Party: Carmen Brittinger, KKS Sponsor representative, Philipps University Marburg Medical Center Identifier: NCT01197482    
Other Study ID Numbers: AZ 109/09
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Keywords provided by Carmen Brittinger, Philipps University Marburg Medical Center:
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases