Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

NCT ID: NCT00830882

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1:levosalbutamol

2 puffs four times a day for 2 weeks

Group Type: EXPERIMENTAL

levosalbutamol

Intervention Type: DRUG

2 puffs four times a day for 2 weeks

2: racemic salbutamol

2 puffs four times a day for 2 weeks

Group Type: ACTIVE_COMPARATOR

racemic salbutamol

Intervention Type: DRUG

2 puffs four times a day for 2 weeks

3: Placebo

2 puffs four times a day for 2 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

2 puffs four times a day for 2 weeks

Interventions

levosalbutamol

2 puffs four times a day for 2 weeks

Intervention Type: DRUG

racemic salbutamol

2 puffs four times a day for 2 weeks

Intervention Type: DRUG

placebo

2 puffs four times a day for 2 weeks

Intervention Type: DRUG

Other Intervention Names

ventolin; placebo to salbutamol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Brian J Lipworth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karine L Clearie, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

Asthma and Allergy Research Group

Brian J Lipworth, MBchB

Role: STUDY_DIRECTOR

Asthma and Allergy Research Group

Locations

Asthma and Allergy Research Group

Dundee, Angus, United Kingdom

Countries

United Kingdom

Other Identifiers

NAI007

Identifier Type: -

Identifier Source: org_study_id