A proof of concept study to evaluate rebound trough airway hyper-responsiveness after single and chronic dosing with levosalbutamol and racemic salbutamol in persistent asthmatics - Rebound trough airway hper-responsiveness with levo and racemic salbutamol

• Conditions: asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-005160-27-GB
• Lead Sponsor: The University of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-28
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Mild to moderate stable asthmatics on = 2000µg BDP or equivalent, who are methacholine responsive PC20< 4 mg/ml
2.>1dd change in methacholine PC20 after the administration of racemic salbutamol
3.Male or female 18-65
4.Informed Consent
5.Ability to comply with the requirements of the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified