Effects of Particle Size in Small Airways Dysfunction

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The airways 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 do not 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 inhaler formulations have been developed that have a much smaller particle size than other standard formulations. These formulations have been shown to go further into the lungs, thus getting into the smaller airways. In this study we aim to compare the two extremes of available long acting beta agonists in terms of particle size i.e. extra fine formoterol (Atimos) versus coarse particle salmeterol (Serevent)in asthmatics with abnormal small airway function using a breathing test called impulse oscillometry. By using this test we will be able to find out whether using an extrafine particle inhaler improves small airway function.

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

Details

• Lead Sponsor: University of Dundee
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Formoterol Fumarate; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• Male or female volunteers aged at least 16 years with a diagnosis of asthma

• Persistent severe small airways dysfunction on impulse oscillometry with R5 > 150% and R5-R20 > 0.05 kPa/L.s despite taking ICS or inhaled corticosteroids / long-acting beta-agonists

• FEV1 > 60 %

• Ability to give informed consent

• Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria:

• Participants already receiving extra-fine particle long-acting beta agonists

• Other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or alergic allergic bronchopulmonary aspergillosis

• An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement

• Smoking within one year or 10 pack year history

• Any clinically significant medical condition that may endanger the health or safety of the participant

• Participation in another trial within 30 days before the commencement of the study

• Pregnancy or lactation