Asthma
Conditions
Keywords
asthma, levosalbutamol, genotype, bronchoprotection
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 basis of their beta-2 adrenoreceptor polymorphisms.
Interventions
DRUGlevosalbutamol
2 puffs four times a day for 2 weeks
2 puffs four times a day for 2 weeks
DRUGplacebo
2 puffs four times a day for 2 weeks
Sponsors
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent 2. Methacholine responsive PC20\< 4 mg/ml 3. \>1dd change in methacholine PC20 after the administration of racemic Salbutamol. 4. Male or female 18-65 5. Informed Consent 6. Ability to comply with the requirements of the protocol
Exclusion criteria
1. Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms. 2. The use of oral corticosteroids within the last 3 months. 3. Recent respiratory tract infection (2 months). 4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis. 5. 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. 6. Any significant abnormal laboratory result as deemed by the investigators 7. Pregnancy, planned pregnancy or lactation 8. Known or suspected contra-indication to any of the IMP's 9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Methacholine challenge | Before and 30 mins after drug administration, and after 2 weeks of chronic treatment |
Secondary
| Measure | Time frame |
|---|---|
| Salbutamol pharmacokinetics | over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period |
| Spirometry | before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing |
| potassium | before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing |
Countries
United Kingdom
Outcome results
None listed