NCT01295255

Brief Summary

Allergic rhinitis (AR) and asthma are considered as "one airway, one disease". Although there is increasing evidence for an association between allergy and depression, it remains unknown if the relationship between AR and asthma has extra influence on the psychological status of the patients. The aim of our study was to investigate the influence pattern of asthma on the psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to analyze the psychological status of 524 individuals with AR. Independent sample T-tests, one-way ANOVA and multivariate ANOVA were used for data analyses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
524

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

February 14, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

February 11, 2011

Last Update Submit

February 11, 2011

Conditions

Keywords

Allergic rhinitisPsychological statusAsthmaAeroallergen

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

524 affected individuals (311 males and 213 females) with AR were prospectively recruited from the rhinology clinic of the Otolaryngology, Head and Neck Surgery Department of Beijing Tongren Hospital from February 2009 to November 2009.

You may qualify if:

  • Patients suffered from rhinitis symptoms such as nasal itching, sneezing, nasal obstruction and running nose, all patients had not undergone any medicine therapy in the past one week; nasal endoscopy showed a pale and edematous nasal mucosa, nasal discharge and swollen inferior turbinates. Every nasal symptom was scored on Visual analog scale (VAS, 0-3 score) respectively. A score of 0 indicated no nasal symptom, 1 indicated slight nasal symptoms, 2 indicated obvious nasal symptom, but which could still be endured, and 3 indicated obvious nasal symptoms that could not be endured;
  • Age between 16 to 60 years;
  • A positive skin prick test (SPT)to at least one allergen, the level of response equal to or exceeding ++. The following inhalant allergens were tested: Der p; Der f; Animal hair; Trees; Grasses; Cereals; Mugwort; Dandelion; Giant ragweed; Chenopodium album; Humulus; Locust; Blatella germanica; Pine; Plantain; Curvularia lunata; Candida albicans; Penicillium notatum; Alternaria tenuis and Aspergillus fumigatu. The reactions were evaluated based on the mean wheal diameter at 15 minutes after application of the extracts. The mean diameters of each allergen wheals were calculated from the sum of the largest measurement across the wheal and the largest wheal measurement perpendicular to this divided by two. In addition, we calculated the skin index (SI) as the ratio of allergen weal diameter divided by the histamine weal size. The SPT result for each allergen was defined in terms of the SI value as follows: +: SI≤0.5; ++: 0.5\<SI≤1.0; +++: 1.0\<SI≤2.0; ++++: SI\>2.0.

You may not qualify if:

  • AR combined with hypertension, diabetes or other chronic diseases;
  • AR combined with tumor in the nasal cavity;
  • AR combined with eczema;
  • Acute infection in the past one week;
  • Failure to complete the questionnaires;
  • AR patients undergoing negative life events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypersensitivityRespiratory Tract DiseasesRhinitis, AllergicAsthma

Condition Hierarchy (Ancestors)

Immune System DiseasesRhinitisNose DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • DeMin Han, Phd

    Beijing Tongren Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2011

First Posted

February 14, 2011

Study Start

February 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

February 14, 2011

Record last verified: 2011-01