Inhaled Steroids and Control of Severe Asthma (INHALE)

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

Study Overview

• Status: Terminated
• Conditions: Severe Persistent Asthma

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• Germany
  • Giessen, Germany, 35392
    • Justus-Liebig-University Giessen
  • Greifenstein, Germany
    • Lungenfachklinik Waldhof Elgershausen
  • Marburg, Germany
    • Philipps-Universitat Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with severe persistent asthma

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	38 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized asthma related quality of life questionnaire (AQLQs)	AQLQs will be completed at screening, randomization, crossover and at end of study	38 weeks
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.	38 weeks
Lung function	Pulmonary function tests (PFT) will be performed and lung function will be assessed by means of spirometry and body plethysmography.	38 weeks
Diffusing capacity for carbon monoxide	Diffusing capacity for carbon monoxide will be assessed at rest and holding breath at full inspiration.	38 weeks
Capillary blood gas analysis	Capillary blood gas analysis will be obtained from the arterialized ear lobe.	38 weeks
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).	38 weeks
Cell differential in induced sputa	Induced sputum will be obtained at screening if not done within the previous 2 years.	1 day
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.	38 weeks

Collaborators and Investigators

• Sponsor: University of Giessen
• Collaborators: Activaero GmbH
• Investigators: Principal Investigator: Andreas Guenther, MD, University of Gießen

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: asthma; inhalation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AZ 109/09