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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01197482
Recruitment Status : Recruiting
First Posted : September 9, 2010
Last Update Posted : December 15, 2015
Activaero GmbH
Information provided by (Responsible Party):
Andreas Guenther, University of Giessen

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

Study Type : Observational
Estimated Enrollment : 20 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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, Senior)
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

Contact: Andreas Guenther, MD +49 641 9942 ext 502

Lungenfachklinik Waldhof Elgershausen Recruiting
Elgershausen. Greifenstein, Germany
Contact: Andreas Guenther, MD    +49 6449 927 ext 262      
Principal Investigator: Andreas Guenther, MD         
Sub-Investigator: Benjamin Loeh, MD         
Justus-Liebig-University Giessen Recruiting
Giessen, Germany, 35392
Contact: Andreas Guenther, MD    +49 641 9942 ext 502      
Principal Investigator: Andreas Guenther, MD         
Sub-Investigator: Daniel von der Beck, MD         
Philipps-Universität Marburg Not yet recruiting
Marburg, Germany
Contact: Claus Vogelmeier, MD    +49 6421 586 ext 6451      
Principal Investigator: Claus Vogelmeier, MD         
Sub-Investigator: Silke Mronga, MD         
Sponsors and Collaborators
University of Giessen
Activaero GmbH
Principal Investigator: Andreas Guenther, MD University of Giessen

Responsible Party: Andreas Guenther, Prof. Dr. med, University of Giessen Identifier: NCT01197482     History of Changes
Other Study ID Numbers: AZ 109/09
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Andreas Guenther, University of Giessen:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases