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

NCT01699165 | Completed DMC

• 3 other identifiers: 1202-2CIV-12-06-0071211-10-72-371-12.
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

rhinitis; allergic; seasonal; double blind; doubleblind; randomized; randomised; placebo; crossover; clinical; nasal; filter; controlled; trial; hayfever; hay; fever; efficacy; safety; prevention; adult; grass; pollen; symptom; Total nasal symptom score; acoustic rhinometry

Outcome Measures

Primary Outcomes (1)

• Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score

  To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.

  Day 1 and day 15

Secondary Outcomes (1)

• Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry

  Day 1 and day 15

Other Outcomes (5)

• To assess symptoms using a VAS Scale symptoms questionnaire (PC)

  Day 1 and Day 15

• To assess the tolerability and safety of nasal filters

  Day 1 and Day 15

• To assess the effects on the lower airway via nitrogen oxide measurements during expiration.

  Day 1 and Day 15

Study Arms (2)

Placebo Nasal filter

SHAM COMPARATOR

Placebo treatment

Device: Placebo nasal filter

Nasal Filter

ACTIVE COMPARATOR

Active treatment

Device: Nasal filter

Interventions

Nasal filter DEVICE

Active nasal filter

Nasal Filter

Placebo nasal filter DEVICE

Placebo nasal filter

Placebo Nasal filter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Spirare ApS: collaborator

Study Sites (1)

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

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis; Fever

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Torben Sigsgaard, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: October 3, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

DK (1)