Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

rhinitisallergicseasonaldouble blinddoubleblindrandomizedrandomisedplacebocrossoverclinicalnasalfiltercontrolledtrialhayfeverhayfeverefficacysafetypreventionadultgrasspollensymptomTotal nasal symptom scoreacoustic 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)

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 filterDevice

Active nasal filter

Nasal Filter

Placebo nasal filterDevice

Placebo nasal filter

Placebo Nasal filter

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Spirare ApS
Type not reportedcollaborator
University of Aarhus
Otherlead

Study Sites (1)

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

Aarhus, 8200, Denmark

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitisFever

Condition Hierarchy (Ancestors)

Rhinitis, AllergicNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsBody Temperature ChangesSigns and Symptoms

Study Officials

Torben Sigsgaard, Professor
Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (5)

Study Arms (2)

Placebo Nasal filter

Nasal Filter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (5)

Study Arms (2)

Placebo Nasal filter

Nasal Filter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations