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Clinical Trials/EUCTR2009-017356-28-GB
EUCTR2009-017356-28-GB
Active, not recruiting
Phase 1

Evaluation of Beta Blockers for the Treatment of Asthma. A randomised controlled trial of propranolol.

niversity of Dundee0 sites15 target enrollmentMarch 17, 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
asthma
Sponsor
niversity of Dundee
Enrollment
15
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 17, 2010
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Dundee

Eligibility Criteria

Inclusion Criteria

  • Male and female volunteers with stable mild intermittent or mild persistent asthma. Stable defined as: FEV1 \>80% predicted with diurnal FEV1 variation \<30% when LABA washed out. Methacholine PC20 \<4mg/ml.
  • Male and female participants, aged between 18 to 65\.
  • Ability to perform spirometry, IOS, bronchial challenge and all domiciliary measurements.
  • Ability to obtain Informed consent.
  • Mild to Moderate Asthmatics taking \=1000µg BDP per day or equivalent.
  • Withold LABAs for 1 week prior to study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • Uncontrolled symptoms of asthma.
  • Resting BP\<110 systolic or HR\<60\.
  • Pregnancy or lactation.
  • Known or suspected sensitivity to the IMP(s).
  • Inability to comply with protocol.
  • Any degree of heart block.
  • Rate limiting medication including ß blockers, rate limiting Calcium Channel Blockers and Amiodarone.
  • Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
  • An asthma exacerbation within the last 6 months.

Outcomes

Primary Outcomes

Not specified

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