None listed
Conditions
Brief summary
The study aims to provide proof-of-concept support for the use of botulinum toxin in difficult-to-treat asthma with vocal cord dysfunction.
Interventions
Botulinum toxin injection of unilateral vocal cord.
Injection done in 3 ways: through skin under electromyography, through the skin under endoscopic guidance and direct injection under general anesthetic.
Dose 2.5-5U per injection.
Observation for 3 months.
Repeat injection after 1-3 months if symptoms recurrent (ACT score same or lower than baseline).
Injection technique was at the discretion of the ENT surgeon and doses were based on his experience injecting vocal cord dystonias (>300 cases).
Sponsors
Monash Medical Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Difficult-to-treat asthma unresponsive to optimised treatments, Vocal cord dysfunction on imaging, ACT score <15
Exclusion criteria
Allergy to botulinum toxin Other known laryngeal disease
Outcome results
None listed