Efficacy of cellulose powder in reduction allergic symptoms in children with allergic rhinitis

• Register: TCTR
• Last refreshed on: 1 April 2024
• Main ID: TCTR20150325001
• Date of registration: 25/03/2015
• Prospective Registration: Yes
• Primary sponsor: Clinical Research Center, Faculty of Medicine Ramathibodi Hospital, Mahidol University
• Public title: Efficacy of cellulose powder in reduction allergic symptoms in children with allergic rhinitis
• Scientific title: Efficacy of cellulose powder in reduction allergic symptoms in children with allergic rhinitis
• Date of first enrolment: 31/03/2015
• Target sample size: 100
• Recruitment status: Enrolling by invitation
• URL: https://www.thaiclinicaltrials.org/show/TCTR20150325001
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Natchanun Klangkalya
• Affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University

• Name: Natchanun Klangkalya
• Affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age 8-18 years old
2. Have persistent rhinitis symptoms for a minimum of 1 year
3. Positive skin prick test (SPT) for house dust mite allergen (D.pteronyssinus)
4. Positive nasal challenge test for D.pteronyssinus

Exclusion criteria: 1. Patients with asthma, upper respiratory tract infections or nasal deformities
2. Patients with multiple sensitization from SPT
3. Received and receiving allergen immunotherapy
4. Patients with severe persistent AR


Age minimum: 8 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Allergic rhinitis
Cellulose powder
Dust mite allergy
Total nasal symptoms score
Nasal provocation test
Rhinomanometry
PNIF

Allergic rhinitis Dust mite allergy
Allergic rhinitis
Cellulose powder
Dust mite allergy
Total nasal symptoms score
Nasal provocation test
Rhinomanometry
PNIF

Intervention(s)

Active Comparator Device,Placebo Comparator No treatment

Cellulose powder,Placebo (Lactose powder)

Cellulose powder spray from natural origin, delivered through a patented delivery system. It is a medical device indicated in the prevention of airborne allergies.

,Placebo is made from lactose powder. It's safe for using via intranasal route.
It is made to resemble drugs; both packaging and labelling

Primary Outcome(s)

clinical symptoms of AR before and after treatment with cellulose powder 1 month after treatment with cellulose powder/placebo TNSS, Severity of clinical symptoms during nasal challenge, PNIF, Anterior Rhinomanometry

Secondary Outcome(s)

inflammatory response before and after treatment with cellulose powder 1 month after treatment with cellulose powder/placebo Nasal scraping for cellular analysis before and after treatment

Source(s) of Monetary Support

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Secondary Sponsor(s)

Allergy and Immunology Unit, Department of Pediatrics, Ramathibodi

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Committee of Human Rights Related to Research Involving Human Subjects

[phone] Ext.

Results

• Date Completed: 31/03/2016