Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

Asthma Clinical Trial

— NAI009  

Official title:

A Proof of Concept Study to Evaluate the Trough Bronchoprotection Conferred by Chronic Dosing With Levosalbutamol and Racemic Salbutamol in Persistent Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831376
• Other study ID #: NAI009
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
• racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
• placebo
Patients will be asked to take two puffs four times a day for 2 weeks

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group	Dundee	Angus

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Anderson WJ, Short PM, Williamson PA, Morrison AE, Palmer C, Tavendale R, Lipworth BJ. Proof-of-concept evaluation of trough airway hyper-responsiveness following regular racemic or levosalbutamol in genotype-stratified steroid-treated persistent asthmati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	methacholine challenge		before and after 2 week study period
Secondary	spirometry		before and after 2 week study period
Secondary	nitric oxide levels		before and after 2 week study period
Secondary	symptom scores		before and after 2 week study period
Secondary	Bmax and Emax		before and after 2 week study period