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Completed

NCT Number: NCT01699165

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal filter

Device

Active nasal filter

Placebo nasal filter

Device

Placebo nasal filter

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

    Time frame: Day 1 and day 15

    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.

Secondary outcomes

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

    Time frame: Day 1 and day 15

    To assess the effects of active nasal filters on intranasal volume 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. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test.

Other outcomes

  1. To assess symptoms using a VAS Scale symptoms questionnaire (PC)

    Time frame: Day 1 and Day 15

    On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post

  2. To assess the tolerability and safety of nasal filters

    Time frame: Day 1 and Day 15

    By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure

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

    Time frame: Day 1 and Day 15

    On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure

  4. Spirometric lung function

    Time frame: Day 1 and Day 15

    On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours

  5. Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Ocular Symptom Score (TOSS)

    Time frame: Day 1 and day 15

    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 Ocular Symptom Score (TOSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Spirare ApS

Registry information

Official study title

Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 3, 2012
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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