Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI007)

June 11, 2012 updated by: Brian J Lipworth, University of Dundee

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Asthma and Allergy Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1:levosalbutamol
2 puffs four times a day for 2 weeks
Drug: levosalbutamol
2 puffs four times a day for 2 weeks
Active Comparator: 2: racemic salbutamol
2 puffs four times a day for 2 weeks
Drug: racemic salbutamol
2 puffs four times a day for 2 weeks
Other Names:
  • ventolin
Placebo Comparator: 3: Placebo
2 puffs four times a day for 2 weeks
Drug: placebo
2 puffs four times a day for 2 weeks
Other Names:
  • placebo to salbutamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Methacholine challenge
Time Frame: Before and 30 mins after drug administration, and after 2 weeks of chronic treatment
Before and 30 mins after drug administration, and after 2 weeks of chronic treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Salbutamol pharmacokinetics
Time Frame: over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period
over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period
Spirometry
Time Frame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
potassium
Time Frame: before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: Karine L Clearie, MBBS, MRCP, Asthma and Allergy Research Group
  • Study Director: Brian J Lipworth, MBchB, Asthma and Allergy Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAI007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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