NCT01936818

Brief Summary

A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen Challenge (NAC) in a Dust Mite Population

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

September 3, 2013

Last Update Submit

October 21, 2015

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • TNSS= total nasal symptoms score

    15 minutes

Secondary Outcomes (1)

  • Individual nasal symptoms

    15 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects at least 18 years of age of either sex and any race

You may qualify if:

  • be at least 18 years of age
  • positive ST to Dust Mite
  • history of allergic rhinitis

You may not qualify if:

  • no active infections
  • no disallowed medications
  • no nasal anatomical deformities or nasal surgical interventions in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ora Clinical Research Center

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 6, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

US(1)