BOTOX for vocal cord dysfunction in severe asthma

Botulinum Toxin to treat vocal cord dysfunction in severe asthma

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001270909

Acronym

VCD BOTOX

Enrollment

Registered

2011-12-12

Start date

2011-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Asthma is a common condition and severe and difficult-to-treat in up to 5-20% of patients. Vocal cord dysfunction (VCD) is a disorder characterised by inappropriate closure of the vocal cords during respiration. Numerous asthmatics have VCD co-existing with asthma. Recent studies have detected VCD in as many as 50% of cases with Difficult-To-Treat-Asthma. Botulinium Toxin has been shown to effectively reverse the detrimental effects of VCD. This study looks at two hypotheses: 1. That in patients with VCD and DTTA, botulinium toxin treatment reduces VCD compared with saline control; 2. That in patients with VCD and DTTA, botulinium toxin treatment is associated with improvement in symptom-based, but not physiological, measures of asthma control, compared with saline control.

Interventions

Botulinium Toxin 3 units (1.5 units to each thyro-arytenoid muscle = 0.1ml total volume) will be injected into the thyroarytenoid muscle (vocal cord) localised by using Electromyography. Percutaneous transcricothyroid injection is the method of injection to be used. Treatment will occur on one occasion only for the purpose of this study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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; Pregnancy

Outcome results