Trial record 9 of 60 for:    Open Studies | "Urticaria"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Jettanong Klaewsongkram, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT02000648
First received: November 24, 2013
Last updated: July 21, 2014
Last verified: July 2014
  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 Chulalongkorn University:

Primary Outcome Measures:
  • The recalcitrant symptoms of chronic rhinitis or chronic urticaria [ Time Frame: Baseline and 2 months after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients diagnosed with chronic rhinitis or chronic urticaria
Adult patients diagnosed with chronic rhinitis or chronic urticaria and followed-up at Allergy Clinics, King Chulalongkorn Memorial Hospital and Chulalongkorn University Health Service Center

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 24, 2013
Last Updated: July 21, 2014
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Urticaria
Rhinitis, Allergic, Perennial
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014