Status:
WITHDRAWN
Peak 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 peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the ba...
Eligibility Criteria
Inclusion
- Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent
- 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 :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00830882
Start Date
January 1 2009
End Date
January 1 2010
Last Update
June 12 2012
Active Locations (1)
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1
Asthma and Allergy Research Group
Dundee, Angus, United Kingdom, DD1 9SY