Status:
COMPLETED
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Lead Sponsor:
University of Dundee
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patie...
Eligibility Criteria
Inclusion
- Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20\< 4 mg/ml
- \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
- Male or female 18-65
- Informed Consent
- Ability to comply with the requirements of the protocol
Exclusion
- Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
- The use of oral corticosteroids within the last 3 months.
- Recent respiratory tract infection (2 months).
- Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
- Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
- Any significant abnormal laboratory result as deemed by the investigators
- Pregnancy, planned pregnancy or lactation
- Known or suspected contra-indication to any of the IMP's
- Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00831376
Start Date
January 1 2009
End Date
April 1 2012
Last Update
April 12 2019
Active Locations (1)
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1
Asthma and Allergy Research Group
Dundee, Angus, United Kingdom, DD1 9SY