Inhaled Steroids and Control of Severe Asthma (INHALE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Giessen.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Activaero GmbH
Hessen Agentur
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01197482
First received: August 18, 2010
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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
Severe Persistent Asthma

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Asthma control [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    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:
  • Standardized asthma related quality of life questionnaire (AQLQs) [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    AQLQs will be completed at screening, randomization, crossover and at end of study

  • Steroid, fluticasone and reliever medication use [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.

  • Capillary blood gas analysis [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Induced sputum will be obtained at screening if not done within the previous 2 years.

  • Adrenal function [ Time Frame: 38 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with severe persistent asthma

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197482

Contacts
Contact: Andreas Guenther, MD +49 641 9942 ext 502 andreas.guenther@innere.med.uni-giessen.de

Locations
Germany
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         
Sub-Investigator: Mirela Cristina Ciotor, 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: Beate Enke, MD         
Sub-Investigator: Kreckel Andree, MD         
Sub-Investigator: Philipp Markart, 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
Hessen Agentur
Investigators
Principal Investigator: Andreas Guenther, MD Justus-Liebig-University Giessen
  More Information

No publications provided

Responsible Party: Andreas Günther, MD, Justus-Liebig-University Giessen
ClinicalTrials.gov Identifier: NCT01197482     History of Changes
Other Study ID Numbers: AZ 109/09
Study First Received: August 18, 2010
Last Updated: September 10, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
asthma
inhalation

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

ClinicalTrials.gov processed this record on April 22, 2014