Allergic RhinitisNCT02000648
Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand
An observational study of Allergic Rhinitis and Non-allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Observation study of patients with chronic rhinitis or chronic urticaria in Thailand Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Allergic Rhinitis, Non-allergic Rhinitis, Chronic Urticaria
- How many people
- 500 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Apr 2015
- How long will I take part?
- 2 Years
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic rhinitis or chronic urticaria
Who may be able to join
- 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
Who cannot join
- Less than 15 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Observation study of patients with chronic rhinitis or chronic urticaria in Thailand
Read the 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.
- Conditions
- Allergic Rhinitis, Non-allergic Rhinitis, Chronic Urticaria
- Keywords
- Allergic Rhinitis, Non-allergic Rhinitis, Chronic urticaria
- Medical subject headings
- Rhinitis, Allergic, Common Cold, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with chronic rhinitis or chronic urticaria | Patients diagnosed with chronic rhinitis/urticaria and followed-up at Allergy Clinics, Chulalongkorn University |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recalcitrant symptoms of chronic rhinitis or chronic urticaria
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".
Measured: Baseline and 2 months after treatment
Secondary outcomes (1)
The correlation between symptom severity and quality of life
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jettanong Klaewsongkram, Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000648
- Sponsor's protocol ID
- Chula-ARC 001/13
- Status last verified
- Feb 2019
- First submitted
- 24 Nov 2013
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jaruvongvanich V, Mongkolpathumrat P, Chantaphakul H, Klaewsongkram J. Extranasal symptoms of allergic rhinitis are difficult to treat and affect quality of life. Allergol Int. 2016 Apr;65(2):199-203. doi: 10.1016/j.alit.2015.11.006. Epub 2016 Jan 19.
PubMed 26810441
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand
- ClinicalTrials.gov ID
- NCT02000648
- Acronym / sponsor ID
- Chula-ARC 001/13
- Conditions
- Allergic Rhinitis, Non-allergic Rhinitis, Chronic Urticaria
- Keywords
- Allergic Rhinitis, Non-allergic Rhinitis, Chronic urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Dec 2013 (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.
Observation study of patients with chronic rhinitis or chronic urticaria in Thailand
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with chronic rhinitis or chronic urticaria | – | –Patients diagnosed with chronic rhinitis/urticaria and followed-up at Allergy Clinics, Chulalongkorn University |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic rhinitis or chronic urticaria
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Less than 15 years of age
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
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".
1 secondary outcome
The correlation between symptom severity and quality of life
Time frame: At baseline
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 18 Feb 2019.
- Derived from this study: PubMed 26810441Jaruvongvanich V, Mongkolpathumrat P, Chantaphakul H, Klaewsongkram J. Extranasal symptoms of allergic rhinitis are difficult to treat and affect quality of life. Allergol Int. 2016 Apr;65(2):199-203. doi: 10.1016/j.alit.2015.11.006. Epub 2016 Jan 19.
- Extranasal symptoms of allergic rhinitis are difficult to treat and affect quality of lifeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
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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.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Non-allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
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 1 inclusion and 1 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
The recalcitrant symptoms of chronic rhinitis or chronic urticaria (time frame: Baseline and 2 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000648, which also lists 1 linked publication.
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 18 Feb 2019.