Cellulose Powder Against Grass Pollen Allergic Rhinitis
CPARGPDBPC
A Nasally Applied Cellulose Powder in Seasonal Allergic Rhinitis in Adults With Grass Pollen Allergy: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study
1 other identifier
interventional
108
2 countries
3
Brief Summary
Background: A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen counts. The present study in grass pollen-allergic adults used the same basic design. Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were used as reminders of treatment and reporting of symptom scores.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedFebruary 1, 2017
January 1, 2017
1 month
December 12, 2016
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Symptoms of allergic rhinitis
Group total of symptoms scored retrospectively once daily
Day 1-28 of treatment period
Secondary Outcomes (4)
Adverse events
Day 1-28 and day 32
Use of rescue medication
Treatment period day 1-28
Global opinion of the efficacy
Day 32, after completed treatment
Guess on obtained treatment
Day 32, after completed treatment
Study Arms (2)
Active
ACTIVE COMPARATORThe patients were randomly assigned to active (Nasaleze cellulose powder) or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Placebo
PLACEBO COMPARATORThe patients were randomly assigned to active or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Interventions
Eligibility Criteria
You may qualify if:
- Patient with a history of typical symptoms of hay fever during late spring or early summer
- Mild or moderate severity of symptoms of seasonal allergic rhinitis.
- Positive allergy test for grass pollen allergy.
- Voluntarily given written informed consent to study participation encompassing consent to data recording and verification procedures;
- Patients are able and willing to comply with the requirements of the study protocol.
- Patients who have not received any pollen disease treatment for one week prior to the study.
You may not qualify if:
- Previous treatment with nasal steroids or current indications for the administration of nasal steroids.
- Nasal symptoms during all seasons of the year or during spring time preceding the grass pollen season.
- Clinical signs of predominating nasal obstruction. The patient must be judged to be able to reach the nasal cavity with the study powder.
- Other respiratory or chronic diseases.
- Previous use of the study product
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nasaleze International Ltdlead
- Göteborg Universitycollaborator
Study Sites (3)
Departments of Pediatrics and Biological and Environmental Sciences
Gothenburg, Sweden
Mechanikov Dnipropetrovsk Regional Clinical Hospital, Departmnet of Profpathology, Zhovteneva sq 14
Dnipro, 49106, Ukraine
Kharkiv National Medical University Department of Internal medicine propedeutics No 2 4 Lenin str
Kharkiv, 61022, Ukraine
Related Publications (1)
Aberg N, Ospanova ST, Nikitin NP, Emberlin J, Dahl A. A nasally applied cellulose powder in seasonal allergic rhinitis in adults with grass pollen allergy: a double-blind, randomized, placebo-controlled, parallel-group study. Int Arch Allergy Immunol. 2014;163(4):313-8. doi: 10.1159/000360734. Epub 2014 Apr 29.
PMID: 24852424RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
February 1, 2017
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
November 1, 2013
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share