Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI009)

April 10, 2019 updated by: Brian J Lipworth, University of Dundee

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

30

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

    • 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, 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.

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: levosalbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
Patients will be asked to take two puffs four times a day for 2 weeks
Active Comparator: 2: racemic salbutamol
Patients will be asked to take two puffs four times a day for 2 weeks
Patients will be asked to take two puffs four times a day for 2 weeks
Other Names:
  • Ventolin
Placebo Comparator: 3: Placebo
Patients will be asked to take two puffs four times a day for 2 weeks
Patients will be asked to take two puffs four times a day for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
methacholine challenge
Time Frame: before and after 2 week study period
before and after 2 week study period

Secondary Outcome Measures

Outcome Measure
Time Frame
spirometry
Time Frame: before and after 2 week study period
before and after 2 week study period
nitric oxide levels
Time Frame: before and after 2 week study period
before and after 2 week study period
symptom scores
Time Frame: before and after 2 week study period
before and after 2 week study period
Bmax and Emax
Time Frame: before and after 2 week study period
before and after 2 week study period

Collaborators and Investigators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

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 (Actual)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

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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