Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

NCT00830882 | Withdrawn Phase 4

• 1 other identifier: NAI007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; levosalbutamol; genotype; bronchoprotection

Outcome Measures

Primary Outcomes (1)

• Methacholine challenge

  Before and 30 mins after drug administration, and after 2 weeks of chronic treatment

Secondary Outcomes (3)

• Salbutamol pharmacokinetics

  over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period

• Spirometry

  before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing

• potassium

  before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing

Study Arms (3)

1:levosalbutamol

EXPERIMENTAL

2 puffs four times a day for 2 weeks

Drug: levosalbutamol

2: racemic salbutamol

ACTIVE COMPARATOR

2 puffs four times a day for 2 weeks

Drug: racemic salbutamol

3: Placebo

PLACEBO COMPARATOR

2 puffs four times a day for 2 weeks

Drug: placebo

Interventions

levosalbutamol DRUG

2 puffs four times a day for 2 weeks

1:levosalbutamol

racemic salbutamol DRUG

2 puffs four times a day for 2 weeks

Also known as: ventolin

2: racemic salbutamol

placebo DRUG

2 puffs four times a day for 2 weeks

Also known as: placebo to salbutamol

3: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent
• Methacholine responsive PC20\< 4 mg/ml
• \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
• Male or female 18-65
• Informed Consent
• Ability to comply with the requirements of the protocol

You may not qualify if:

• Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
• The use of oral corticosteroids within the last 3 months.
• Recent respiratory tract infection (2 months).
• Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
• 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.
• Any significant abnormal laboratory result as deemed by the investigators
• Pregnancy, planned pregnancy or lactation
• Known or suspected contra-indication to any of the IMP's
• Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Asthma and Allergy Research Group

Dundee, Angus, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Karine L Clearie, MBBS, MRCP

  Asthma and Allergy Research Group

  PRINCIPAL INVESTIGATOR

• Brian J Lipworth, MBchB

  Asthma and Allergy Research Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

GB (1)