Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

Study Overview
=================
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.

Official Title
-----------------
A Proof of Concept Study to Evaluate the Peak Bronchoprotection Conferred by Single and Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: levosalbutamol
* Drug: racemic salbutamol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:levosalbutamol<br>2 puffs four times a day for 2 weeks | Drug: levosalbutamol<br>* 2 puffs four times a day for 2 weeks<br>|
| Active Comparator: 2: racemic salbutamol<br>2 puffs four times a day for 2 weeks | Drug: racemic salbutamol<br>* 2 puffs four times a day for 2 weeks<br>* Other names: ventolin;|
| Placebo Comparator: 3: Placebo<br>2 puffs four times a day for 2 weeks | Drug: placebo<br>* 2 puffs four times a day for 2 weeks<br>* Other names: placebo to salbutamol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methacholine challenge |  | Before and 30 mins after drug administration, and after 2 weeks of chronic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, levosalbutamol, genotype, bronchoprotection