Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

Asthma Clinical Trial

— NAI007  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00830882
• Other study ID #: NAI007
• Status: Withdrawn
• Phase: Phase 4
• First received: January 27, 2009
• Last updated: June 11, 2012
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2012
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levosalbutamol
2 puffs four times a day for 2 weeks
• racemic salbutamol
2 puffs four times a day for 2 weeks
• placebo
2 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methacholine challenge		Before and 30 mins after drug administration, and after 2 weeks of chronic treatment	No
Secondary	Salbutamol pharmacokinetics		over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period	No
Secondary	Spirometry		before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing	No
Secondary	potassium		before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing	Yes