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Severe Persistent AsthmaINHALENCT01197482

Inhaled Steroids and Control of Severe Asthma

An observational study of Severe Persistent Asthma, run by University of Giessen at 3 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Severe Persistent Asthma
How many people
6 participants
Where
3 sitesGermany
Study dates
Sep 2010to 28 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with severe persistent asthma

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Justus-Liebig-University Giessen

    Giessen, 35392

  • Lungenfachklinik Waldhof Elgershausen

    Greifenstein

  • Philipps-Universität Marburg

    Marburg

Other trials in Germany

About this study

Official title: Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)

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

Keywords
asthma, inhalation
Medical subject headings
Asthma, Respiratory Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 38 weeks

Secondary outcomes (8)

  1. Standardized asthma related quality of life questionnaire (AQLQs)

    AQLQs will be completed at screening, randomization, crossover and at end of study

    Measured: 38 weeks

  2. 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.

    Measured: 38 weeks

  3. Lung function

    Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography.

    Measured: 38 weeks

  4. Diffusing capacity for carbon monoxide

    Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.

    Measured: 38 weeks

  5. Capillary blood gas analysis

    Capillary blood gas analysis will be obtained from the arterialized ear lobe.

    Measured: 38 weeks

  6. 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).

    Measured: 38 weeks

  7. Cell differential in induced sputa

    Induced sputum will be obtained at screening if not done within the previous 2 years.

    Measured: 1 day

  8. 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.

    Measured: 38 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completion28 Dec 2018
  4. Study completion28 Dec 2018

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01197482
Sponsor's protocol ID
AZ 109/09
Acronym
INHALE
Status last verified
Nov 2020
First submitted
18 Aug 2010
Last updated
10 Nov 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Persistent Asthma, run by University of Giessen at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma control (time frame: 38 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01197482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.

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