Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000455763
Ethics application status
Approved
Date submitted
3/04/2013
Date registered
19/04/2013
Date last updated
19/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum toxin injection for vocal cord dysfunction in asthma
Scientific title
Botulinum toxin injection for vocal cord dysfunction in asthma - benefits on symptoms and laryngeal imaging
Secondary ID [1] 282235 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 288750 0
Vocal cord dysfunction 288751 0
Condition category
Condition code
Respiratory 289109 289109 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 286845 0
Treatment: Drugs
Comparator / control treatment
No comparator used
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289221 0
Asthma Control Test Score one month after injection.
Timepoint [1] 289221 0
One month
Primary outcome [2] 289385 0
Degree of vocal cord dysfunction detected on Computerised Tomography (CT) imaging of the larynx after one month.
Timepoint [2] 289385 0
One month
Secondary outcome [1] 302058 0
Side efftects immediately after injection, formally after one month and after 3 months. This entailed a history of known possible side-effects (loss of voice, dysphagia, choking, cough) as well as any spontaneous adverse symptoms.
Timepoint [1] 302058 0
Three months

Eligibility
Key inclusion criteria
Difficult-to-treat asthma unresponsive to optimised treatments,
Vocal cord dysfunction on imaging,
ACT score <15
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to botulinum toxin
Other known laryngeal disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Although a treatment was given no specific allocation was done. Sequential patients were enrolled at the discretion of the investigators. There was no concealment of allocation.
Patients were selected and enrolled from a severe asthma clinic, treatment given and patient outcomes prospectively collected. The study is can therefore be viewed as interventional since a treatment was given and outcomes were monitored.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - see above.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Unblinded, proof-of-concept study, no power calculations done.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
28/08/2012
Date of last participant enrolment
Anticipated
1/04/2013
Actual
5/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 835 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 6650 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 286999 0
Hospital
Name [1] 286999 0
Monash Lung & Sleep, Monash Medical Centre
Country [1] 286999 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
246 Clayton Rd
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 285783 0
None
Name [1] 285783 0
Address [1] 285783 0
Country [1] 285783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289044 0
Southern Health Therapeutics/Ethics Committee
Ethics committee address [1] 289044 0
Ethics committee country [1] 289044 0
Australia
Date submitted for ethics approval [1] 289044 0
Approval date [1] 289044 0
27/08/2012
Ethics approval number [1] 289044 0
SHTC-08-12
Ethics committee name [2] 289138 0
Southern Health Research Ethics Committee
Ethics committee address [2] 289138 0
Ethics committee country [2] 289138 0
Australia
Date submitted for ethics approval [2] 289138 0
Approval date [2] 289138 0
16/01/2013
Ethics approval number [2] 289138 0
13004Q

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38942 0
Prof Philip Bardin
Address 38942 0
Monash Medical Centre
246 Clayton Rd
Clayton, Victoria, 3168
Country 38942 0
Australia
Phone 38942 0
61 3 95942281
Fax 38942 0
61 3 95946415
Email 38942 0
philip.bardin@southernhealth.org.au
Contact person for public queries
Name 38943 0
Joanne McKenzie
Address 38943 0
Clinical Trials Coordinator
Monash Lung & Sleep
246 Clayton Rd
Clayton, Victoria, 3168
Country 38943 0
Australia
Phone 38943 0
61 3 95942279
Fax 38943 0
61 3 95946415
Email 38943 0
joanne.mckenzie@southernhealth.org.au
Contact person for scientific queries
Name 38944 0
Philip Bardin
Address 38944 0
Monash Lung & Sleep
Monash Medical Centre
246 Clayton Rd
Clayton, Victoria, 3168
Country 38944 0
Australia
Phone 38944 0
61 3 95942281
Fax 38944 0
61 3 95946415
Email 38944 0
philip.bardin@southernhealth.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.