Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01699165
• Date of registration: 16/08/2012
• Prospective Registration: Yes
• Primary sponsor: University of Aarhus
• Public title: Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
• Scientific title: Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
• Date of first enrolment: December 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01699165
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Torben Sigsgaard, Professor
• Affiliation: Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study
entry. Documented by a positive skin test within 12 months of study enrollment.

- Written informed consent

- Reliable anticonception for fertile women

- Must be able to complete the study

- Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value

- Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L

Exclusion Criteria:

- Positive pregnancy test for fertile women

- Asthma unless mild and only occurring in relation to the grass pollen season as
assessed by the investigator

- Inadequate washout periods in regards to Environmental Exposure Unit (EEU)
appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2
weeks), intranasal or systemic decongestants (3 days), intranasal or systemic
antihistamines (3 days), loratadine (10 days))

- Rhinitis medicamentosa

- Use of long acting anti-histamines

- Documented evidence of acute or chronic sinusitis as determined by individual
investigator

- FEV1 lower than 70 % of predicted value

- Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs
moulds unless symptom free

- Allergic rhinitis requiring medication caused by allergens other than grass unless
symptom free

- Subjects with nasal conditions likely to affect the outcome of the study in the
opinion of the investigator, i.e. anterior nasal septum deviation, nasal septum
perforations, nasal polyps, chronic nasal obstruction or other nasal diseases

- Receipt of immunotherapy with grass pollen within the previous 10 years

- Women who are breastfeeding



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rhinitis, Allergic, Seasonal

Intervention(s)

Device: Placebo nasal filter

Device: Nasal filter

Primary Outcome(s)

Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score [Time Frame: Day 1 and day 15]

Secondary Outcome(s)

Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry [Time Frame: Day 1 and day 15]

Secondary ID(s)

1202-2

1-10-72-371-12.

CIV-12-06-007121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Spirare ApS