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

NCT ID: NCT01699165

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Nasal filter

Placebo treatment

Group Type: SHAM_COMPARATOR

Placebo nasal filter

Intervention Type: DEVICE

Placebo nasal filter

Nasal Filter

Active treatment

Group Type: ACTIVE_COMPARATOR

Nasal filter

Intervention Type: DEVICE

Active nasal filter

Interventions

Nasal filter

Active nasal filter

Intervention Type: DEVICE

Placebo nasal filter

Placebo nasal filter

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spirare ApS

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torben Sigsgaard, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine

Locations

Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

CIV-12-06-007121

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-371-12.

Identifier Type: OTHER

Identifier Source: secondary_id

1202-2

Identifier Type: -

Identifier Source: org_study_id