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Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand

This study is currently recruiting participants.
Verified July 2016 by Jettanong Klaewsongkram, Chulalongkorn University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000648
First Posted: December 4, 2013
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
  Purpose
Observation study of patients with chronic rhinitis or chronic urticaria in Thailand

Condition
Allergic Rhinitis Non-allergic Rhinitis Chronic Urticaria

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand

Resource links provided by NLM:


Further study details as provided by Jettanong Klaewsongkram, Chulalongkorn University:

Primary Outcome Measures:
  • The recalcitrant symptoms of chronic rhinitis or chronic urticaria [ Time Frame: Baseline and 2 months after treatment ]
    The alteration of symptoms at 2 months compared to baseline. Patient's complaining symptoms will be graded as likert scale system (0, 1, 2, 3). Any symptoms at 2 months after treatment that decrease less than 25% from base line based on average likert scale will be defined as "recalcitrant".


Secondary Outcome Measures:
  • The correlation between symptom severity and quality of life [ Time Frame: At baseline ]
    Pearson correlation between total nasal symptom score in patients with rhinitis or urticaria activity score in patients with chronic urticaria and 12-item short form survey version 2 (SF-12 v2) will be analyzed


Other Outcome Measures:
  • Factors affecting therapeutic outcome (composite outcome measure) [ Time Frame: At baseline ]
    Multivariate analysis will be analyzed between age group, gender, allergic status, symptom severity and the magnitude of symptom alteration at 2 months after treatment


Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with chronic rhinitis or chronic urticaria
Patients diagnosed with chronic rhinitis/urticaria and followed-up at Allergy Clinics, Chulalongkorn University

Detailed Description:

All patients presenting with symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per years or symptoms of chronic urticaria for at least 6 weeks will be asked to complete the case report forms asking for details of symptom characteristics, risk factors, personal habits, underlying diseases, and quality of life at the first visit. Investigation results, final diagnosis, and therapeutic interventions will also be recorded by the responsible allergist. On every follow-up appointment, patient symptoms, aggravating factors, medication use and side effects will be completed by patients. New findings, associated diseases, and prescriptions will be completed by allergist. The unfilled variables by patients will be asked in the following visit. Any "non-reported" variables those are unable to retrieve will be treated as missing data for data analysis. The estimated sample size is about 200 new cases per year.

Patient demographic data, clinical presentations, and associated diseases will be reported. The association between clinical characteristics and quality of life will be analyzed. The relationship between clinical manifestations and therapeutic outcomes will be determined.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic rhinitis or chronic urticaria
Criteria

Inclusion Criteria:

  • Have symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per year or symptoms of chronic urticaria for at least 6 weeks

Exclusion Criteria:

  • Less than 15 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000648


Contacts
Contact: Jettanong Klaewsongkram, MD 02-2564152 Jettanong.K@chula.ac.th

Locations
Thailand
Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Principal Investigator: Jettanong Klaewsongkram, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jettanong Klaewsongkram, Ass. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02000648     History of Changes
Other Study ID Numbers: Chula-ARC 001/13
First Submitted: November 24, 2013
First Posted: December 4, 2013
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jettanong Klaewsongkram, Chulalongkorn University:
Allergic Rhinitis
Non-allergic Rhinitis
Chronic urticaria

Additional relevant MeSH terms:
Urticaria
Rhinitis
Rhinitis, Allergic
Common Cold
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Vascular
Skin Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases