Status:
COMPLETED
IPF Drug Deposition Study
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
Idiopathic pulmonary fibrosis is a relentlessly progressive disease that is responsible for the deaths of over 5000 people in the UK each year. At present, despite a dramatic increase in clinical tria...
Eligibility Criteria
Inclusion
- diagnosis of definite or probable idiopathic pulmonary fibrosis as defined by the ATS/ERS consensus criteria
Exclusion
- co-existent respiratory disease
- use of B2 agonists in preceding two weeks
- DLco and/or FVC falling outside the criteria for either mild or severe IPF.
- Ongoing involvement in clinical trials assessing novel IPF therapies.
- Previous adverse reaction to short or long acting β2 agonist.
- Pregnancy or active breast feeding
- Any contraindication to taking inhaled beta-2 adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study.
- an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01457261
Start Date
April 1 2012
End Date
November 1 2014
Last Update
November 5 2014
Active Locations (1)
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1
Royal Brompton Hospital
London, London, United Kingdom, SW3 6NP