HypersensitivityNCT01295255
Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients
An observational study of Hypersensitivity and Psychologic Factors in Physical Conditions Classified Elsewhere, run by Beijing Tongren Hospital.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Hypersensitivity, Psychologic Factors in Physical Conditions Classified Elsewhere, Respiratory Tract Diseases
- How many people
- 524 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Hypersensitivity, Psychologic Factors in Physical Conditions Classified Elsewhere, Respiratory Tract Diseases, Allergic Rhinitis
- Keywords
- Allergic rhinitis, Psychological status, Asthma, Aeroallergen
- Medical subject headings
- Hypersensitivity, Respiratory Tract Diseases, Rhinitis, Allergic, Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Investigators
- DeMin Han, Phd, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295255
- Sponsor's protocol ID
- 1130
- Status last verified
- Jan 2011
- First submitted
- 11 Feb 2011
- Last updated
- 14 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT01295255
- Acronym / sponsor ID
- 1130
- Conditions
- Hypersensitivity, Psychologic Factors in Physical Conditions Classified Elsewhere, Respiratory Tract Diseases, Allergic Rhinitis
- Keywords
- Allergic rhinitis, Psychological status, Asthma, Aeroallergen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DeMin Han, Phd principal investigator
Beijing Tongren Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity and Psychologic Factors in Physical Conditions Classified Elsewhere, run by Beijing Tongren Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2011.