Status:
COMPLETED
Effects of Particle Size in Small Airways Dysfunction
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 small...
Detailed Description
The small airways are gaining greater recognition for their role in the pathophysiology of persistent asthma and as a relevant target for asthma treatment(1). Pathological abnormalities in the small a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01892787
Start Date
July 1 2013
End Date
December 1 2014
Last Update
April 12 2019
Active Locations (1)
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1
Brian Lipworth
Dundee, United Kingdom, DD1 3AU