Status:
COMPLETED
Targeted Small Airways Therapy in Persistent Asthma
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
Detailed Description
A single centre, open-label, single subject study over a 12-24 week period. Invited participants will receive a written 'Participant Information Sheet' (PIS) detailing the requirements of the trial an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01894048
Start Date
October 28 2013
End Date
June 25 2018
Last Update
September 9 2019
Active Locations (1)
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1
Brian Lipworth
Dundee, United Kingdom, DD1 3AU