A proof of concept study to evaluate the peak bronchoprotection conferred by single and chronic dosing with levosalbutamol and racemic salbutamol in persistent asthmatics. - Peak bronchoprotection with levosalbutamol and salbutamol

Phase 1

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

• Registration Number: EUCTR2007-003652-11-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-28
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

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

Inclusion Criteria

1.Persistent stable asthmatics (FEV1 > 60%) on less than or equal to 2000 micrograms BDP or equivalent.
2.Methacholine responsive PC20 < 4 mg/ml with a 2dd shift in PC20 after 400ug of
salbutamol.
3.Male or female aged 18 - 65 yrs.
4.Able to give informed consent.
5.Able 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 less than or equal to 60% or PEF
variability >30% or with continual daytime or nocturnal symptoms.
2. The use of oral corticosteroids within the preceding 3 months.
3. Recent respiratory tract infection (within preceding 2 months).
4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary TB.
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 IMPs.
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