Targeted Small Airways Therapy in Persistent Asthma

• Status: Completed
• Trial end date: 2018-06-25
• Target enrollment: 0
• Participant gender: All

Summary

The mainstay of asthma treatment is with inhaled steroids (commonly called a 'preventer') to keep the symptoms of asthma under control. Increasing strengths of steroid inhaler may be required in order to gain control of asthma, and this is usually guided both by symptoms and simple measurements of lung function such as peak flow.

The airways (breathing tubes) in the lungs get smaller the further into the lungs they go. Most simple measurements of lung function only reflect the larger 'central' airways and don't provide information on the smaller 'peripheral' airways.Newer measurements have been developed that can now give us accurate information on how the smaller airways are working.Indeed the small airways seem to play a significant role in asthma in terms of inflammation and airway narrowing.

Recently, new types of steroid inhalers have been developed that have a much smaller particle size than other standard inhaled steroids.These have been shown to go deeper into the lungs, thus getting into the smaller airways. There have been a few studies suggesting that this might improve asthma control. However, we do not know if when small airway function is shown to be abnormal, whether this improves with extra-fine particle inhaled steroids, nor whether by improving small airway function specifically this translates into improved asthma control.

In this study we wish to study asthmatic patients who are not completely controlled on standard particle size inhaled steroids, in addition to having evidence of abnormal small airway function. By doing this we want to find out whether changing to the same dose of an extra-fine particle inhaled steroid instead will improve asthma control by getting deeper into the lungs and improving small airway function.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborator: Teva Pharmaceuticals USA
• Treatments: Beclomethasone

Criteria

Inclusion Criteria:

• Male and female volunteers aged 18-65, with persistent asthma

• Asthma Control Questionnaire score >1.0 (at end of run-in)

• FEV1 >60% predicted

• R5>130% predicted and R5-R20>0.03kPa/L/s

• Ability to perform spirometry, impulse oscillometry, bronchial challenge and all domiciliary measurements

• Ability to give informed consent

• Asthmatic patients receiving treatment at Step 2, 3, or 4 of British Thoracic Society asthma guidelines

• Ability to withhold long-acting beta-agonists for the duration of the study

Exclusion Criteria:

• Patients already receiving extra-fine particle inhaled corticosteroids (Qvar, Fostair, Alvesco)

• Pregnancy or lactation

• Known or suspected sensitivity to the Investigational Medicinal Product

• Inability to comply with protocol

• Any clinically significant medical conditions that may either endanger the health or safety of the participant, or jeopardise the protocol

• An asthma exacerbation requiring systemic steroid therapy or lower respiratory tract infection requiring antibiotics within 3 months prior to study commencement

• Participation in previous trial within 30 days