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Completed

NCT Number: NCT00831376

Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group

Dundee, Angus, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are 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

Exclusion criteria

  • 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.

Treatment and study plan

levosalbutamol

Drug

Patients will be asked to take two puffs four times a day for 2 weeks

racemic salbutamol

Drug

Patients will be asked to take two puffs four times a day for 2 weeks

Other names: Ventolin

Placebo

Drug

Patients will be asked to take two puffs four times a day for 2 weeks

Primary outcomes

  1. methacholine challenge

    Time frame: before and after 2 week study period

Secondary outcomes

  1. spirometry

    Time frame: before and after 2 week study period

  2. nitric oxide levels

    Time frame: before and after 2 week study period

  3. symptom scores

    Time frame: before and after 2 week study period

  4. Bmax and Emax

    Time frame: before and after 2 week study period

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

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

Acronym: NAI009

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2009
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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