Inhaled Steroids and Control of Severe Asthma (INHALE)

University of Giessen

Status: Terminated

Conditions: Severe Persistent Asthma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01197482

AZ 109/09

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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