Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

Phase 4

Withdrawn

• Conditions: Asthma
• Interventions: Drug: racemic salbutamol; Drug: placebo; Drug: levosalbutamol

• Registration Number: NCT00830882
• Lead Sponsor: University of Dundee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2: racemic salbutamol	racemic salbutamol	2 puffs four times a day for 2 weeks
3: Placebo	placebo	2 puffs four times a day for 2 weeks
1:levosalbutamol	levosalbutamol	2 puffs four times a day for 2 weeks

Primary Outcome Measures

Name	Time	Method
Methacholine challenge	Before and 30 mins after drug administration, and after 2 weeks of chronic treatment

Secondary Outcome Measures

Name	Time	Method
Spirometry	before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
Salbutamol pharmacokinetics	over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period
potassium	before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing

Trial Locations

Locations (1)

Asthma and Allergy Research Group; 🇬🇧 Dundee, Angus, United Kingdom