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Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI007)

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
levosalbutamol
racemic salbutamol
placebo
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, levosalbutamol, genotype, bronchoprotection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Asthma and Allergy Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1:levosalbutamol

2: racemic salbutamol

3: Placebo

Arm Description

2 puffs four times a day for 2 weeks

2 puffs four times a day for 2 weeks

2 puffs four times a day for 2 weeks

Outcomes

Primary Outcome Measures

Methacholine challenge

Secondary Outcome Measures

Salbutamol pharmacokinetics
Spirometry
potassium

Full Information

First Posted
January 27, 2009
Last Updated
June 11, 2012
Sponsor
University of Dundee
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1. Study Identification

Unique Protocol Identification Number
NCT00830882
Brief Title
Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, levosalbutamol, genotype, bronchoprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:levosalbutamol
Arm Type
Experimental
Arm Description
2 puffs four times a day for 2 weeks
Arm Title
2: racemic salbutamol
Arm Type
Active Comparator
Arm Description
2 puffs four times a day for 2 weeks
Arm Title
3: Placebo
Arm Type
Placebo Comparator
Arm Description
2 puffs four times a day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
levosalbutamol
Intervention Description
2 puffs four times a day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
racemic salbutamol
Other Intervention Name(s)
ventolin
Intervention Description
2 puffs four times a day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo to salbutamol
Intervention Description
2 puffs four times a day for 2 weeks
Primary Outcome Measure Information:
Title
Methacholine challenge
Time Frame
Before and 30 mins after drug administration, and after 2 weeks of chronic treatment
Secondary Outcome Measure Information:
Title
Salbutamol pharmacokinetics
Time Frame
over 30 minutes after drug administration, one day 1 and 14 of a 2 week study period
Title
Spirometry
Time Frame
before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing
Title
potassium
Time Frame
before and 30 mins after drug administration, at single dose and after 2 weeks chronic dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine L Clearie, MBBS, MRCP
Organizational Affiliation
Asthma and Allergy Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian J Lipworth, MBchB
Organizational Affiliation
Asthma and Allergy Research Group
Official's Role
Study Director
Facility Information:
Facility Name
Asthma and Allergy Research Group
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

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Peak Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

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