BOTOX for vocal cord dysfunction in severe asthma

Phase 4

• Conditions: Severe asthma; Vocal cord Dysfunction; Respiratory - Asthma

• Registration Number: ACTRN12611001270909
• Lead Sponsor: Prof Philip Bardin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified