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

This study has been completed.
Sponsor:
Collaborator:
Spirare ApS
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01699165
First received: August 16, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Rhinitis, Allergic, Seasonal
Device: Nasal filter
Device: Placebo nasal filter

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry [ Time Frame: Day 1 and day 15 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To assess symptoms using a VAS Scale symptoms questionnaire (PC) [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: No ]
    On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post

  • To assess the tolerability and safety of nasal filters [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: Yes ]
    By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure

  • To assess the effects on the lower airway via nitrogen oxide measurements during expiration. [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: Yes ]
    On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure

  • Spirometric lung function [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: Yes ]
    On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: December 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Placebo Nasal filter
Placebo treatment
Device: Placebo nasal filter
Placebo nasal filter
Active Comparator: Nasal Filter
Active treatment
Device: Nasal filter
Active nasal filter

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699165

Locations
Denmark
Aarhus University, School of Public Health, Department of Environmental & Occupational Medicine
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Spirare ApS
Investigators
Principal Investigator: Torben Sigsgaard, Professor Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01699165     History of Changes
Other Study ID Numbers: 1202-2, CIV-12-06-007121, 1-10-72-371-12.
Study First Received: August 16, 2012
Last Updated: April 18, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Seasonal
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 24, 2014