Inhaled Steroids and Control of Severe Asthma

NCT01197482 | Terminated

• 1 other identifier: AZ 109/09
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Severe Persistent Asthma

Keywords

asthma; inhalation

Outcome Measures

Primary Outcomes (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.

  38 weeks

Secondary Outcomes (8)

• Standardized asthma related quality of life questionnaire (AQLQs)

  38 weeks

• Steroid, fluticasone and reliever medication use

  38 weeks

• Lung function

  38 weeks

• Diffusing capacity for carbon monoxide

  38 weeks

• Capillary blood gas analysis

  38 weeks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe persistent asthma

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Giessen: lead
• Activaero GmbH: collaborator

Study Sites (3)

Justus-Liebig-University Giessen

Giessen, 35392, Germany

Location

Lungenfachklinik Waldhof Elgershausen

Greifenstein, Germany

Location

Philipps-Universität Marburg

Marburg, Germany

Location

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Guenther, MD

  University of Giessen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KKS Sponsor representative

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

DE (3)