Inhaled Steroids and Control of Severe Asthma

Severe Persistent Asthma Clinical Trial

— INHALE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01197482
• Other study ID #: AZ 109/09
• Status: Terminated
• Start date: September 2010
• Est. completion date: December 28, 2018

Study information

• Verified date: November 2020
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 a conventional MDI.

Study design: open label, cross-over (one AKITA, one MDI arm)

Patients: 20 Patients with severe persistent asthma

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Persistent Asthma

Locations

Country	Name	City	State
Germany	Justus-Liebig-University Giessen	Giessen
Germany	Lungenfachklinik Waldhof Elgershausen	Greifenstein
Germany	Philipps-Universität Marburg	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Activaero GmbH

Country where clinical trial is conducted

Germany, 

Outcome

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