Evaluating the Effects of Intranasal Injection of Botulinum Toxin-A Compared with Cetirizine on Symptoms of Rhinitis in Adult Patients with Allergic Rhinitis
The aim of this study was to evaluate the effects of intranasal Botulinum Toxin-A injection and compare it with cetirizine on symptoms of allergic rhinitis. Fifty adult patients with allergic rhinitis, according to the Allergic Rhinitis and its Impact on Asthma criteria (ARIA), were included into the study, consecutively. Patients randomly received a single dose of intranasal injection of BTX-A (75 IU) or cetirizine (10 mg/day for two months). As the primary outcome, symptoms of rhinitis (based on ARIA) were assessed every two weeks for two months. Quality of life, as the secondary outcome, was evaluated before and after the study using the Rhinasthma questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208261579N3
Registration date:2012-10-03, 1391/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-03, 1391/07/12
Registrant information
Name
Ali Gholamrezaei
Name of organization / entity
Medical Students' Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 8675
Email address
gholamrezaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2010-12-23, 1389/10/02
Expected recruitment end date
2011-12-23, 1390/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Intranasal Injection of Botulinum Toxin-A Compared with Cetirizine on Symptoms of Rhinitis in Adult Patients with Allergic Rhinitis
Public title
Botulinum Toxin-A Compared with Cetirizine in the Treatment of Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Adult patients with allergic rhinitis according to the Allergic Rhinitis and its Impact on Asthma criteria,
2- Having at least three symptoms of sneezing, nasal congestion, and rhinorrhea.
Exclusion criteria:
1- History of nasal anatomic abnormality,
2- Persistent asthma,
3- Long term use of systemic corticosteroids,
4- Malignancy, tuberculosis, diabetes mellitus, or other chronic systemic disease,
5- History of rhinoplasty,
6- Pregnant women,
7- Being on local corticosteroids at the time of enrollment.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomized to the groups based on random table numbers generated by random allocation software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Street, Vice Chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-12-23, 1389/10/02
Ethics committee reference number
388160
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30
ICD-10 code description
Vasomotor and allergic rhinitis
Primary outcomes
1
Description
Sneezing
Timepoint
Baseline and every two weeks for two months
Method of measurement
Allergic Rhinitis and its Impact on Asthma Questionnaire
2
Description
Rhinorrhea
Timepoint
Baseline and every two weeks for two months
Method of measurement
Allergic Rhinitis and its Impact on Asthma Questionnaire
3
Description
Nasal congestion
Timepoint
Baseline and every two weeks for two months
Method of measurement
Allergic Rhinitis and its Impact on Asthma Questionnaire
4
Description
Nasal itching
Timepoint
Baseline and every two weeks for two months
Method of measurement
Allergic Rhinitis and its Impact on Asthma Questionnaire
5
Description
Eye irritation
Timepoint
Baseline and every two weeks for two months
Method of measurement
Allergic Rhinitis and its Impact on Asthma Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and two months after the study
Method of measurement
Rhinasthma Questionnaire
2
Description
Nasal dryness
Timepoint
Every two weeks for two months
Method of measurement
Interview with patient
3
Description
Epistaxis
Timepoint
Every two weeks for two months
Method of measurement
Interview with patient
4
Description
Sleepiness
Timepoint
Every two weeks for two months
Method of measurement
Interview with patient
5
Description
Blurred vision
Timepoint
Every two weeks for two months
Method of measurement
Interview with patient
Intervention groups
1
Description
Intervention:
Patients in the intervention group were treated with a single dose intranasal injection of BTX-A (Dysport, Ipsen Biopharm, Wrexham, UK). The procedure was applied while the patients were in sitting position. Local intranasal anesthesia was done with 10% lidocaine sprayed 10 minutes before the injection. Each vial of 495 IU BTX-A was diluted with 3.3 cc of distilled water (150 IU/cc), and 0.5 cc (75 IU each nasal cavity) of this solution was slowly injected with insulin needle into the anterior part of each inferior turbinate.
Category
Treatment - Drugs
2
Description
Control:
Patients in the control group were treated with cetirizine (Abidi Co., Tehran, IRAN) 10 mg once daily for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Saghi Amini
Street address
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saghi Amini
Position
MD, Otorhinolaryngologist
Other areas of specialty/work
Street address
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
00
Fax
Email
drsaghi210@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saghi Amini
Position
MD, Otorhinolaryngologist
Other areas of specialty/work
Street address
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
00
Fax
Email
drsaghi210@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Saghi Amini
Position
MD, Otorhinolaryngologist
Other areas of specialty/work
Street address
Department of Otorhinolaryngology Head and Neck surgery, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
00
Fax
Email
drsaghi210@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)