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Clinical Trials/ACTRN12611001270909
ACTRN12611001270909Not yet recruitingPhase 4

Botulinum Toxin to treat vocal cord dysfunction in severe asthma

Prof Philip Bardin0 sites46 target enrollmentStarted: December 12, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
46

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 65 Years (—)
Sex
All

Inclusion Criteria

  • Asthma confirmed by airway reversibility (FEV1 >12% and 200mls) OR airway hyperreponsiveness;
  • Subjects with clinical features of severe refractory asthma;
  • Subjects with well documented requirement for regular treatment with high dose ICS;
  • Subjects with well documented requirement for controller medication in addition to high dose ICS;
  • Evidence of optimal medication use;
  • Sub-optimally controlled asthma, as indicated by ACT score <15;
  • Post-bronchodilator FEV1 >40% predicted;
  • VCD demonstrated by 320-slice CT larynx (RATIO below LLN during either inspiration or expiration;

Exclusion Criteria

  • Other significant respiratory disorder;
  • Known vocal cord pathology or diagnosed voice condition other than VCD;
  • Known brain or brainstem cancer, or head and neck cancer;
  • Known neurological disorders or neuromuscular disorders;

Investigators

Sponsor
Prof Philip Bardin

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