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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01295255
Other study ID # 1130
Secondary ID
Status Completed
Phase N/A
First received February 11, 2011
Last updated February 11, 2011
Start date February 2009
Est. completion date November 2009

Study information

Verified date January 2011
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology Commission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 524
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital
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