Rhinitis, Allergic, PerennialPhase 4NCT01115595
Efficacy of Allergen Immunotherapy for Allergic Rhinitis in Thais
A Phase 4 study testing Intervention in people with Rhinitis, Allergic, Perennial, run by Pongsakorn Tantilipikorn at 1 site in Thailand.
Trial summary
The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by symptoms score medication score quality of life immunologic test from blood Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2010to Oct 2014
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
- positive skin prick test to D.p. at 4+ degree
Who cannot join
- steroid dependent asthma
- force expiratory volume (FEV1) less than 70% of predicted value
- previous injection immunotherapy within 2 years
- pregnancy
- medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Rhinology, Faculty of Medicine Siriraj, Mahidol University
Bangkok, 10700
About this study
Official title: Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis
The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by
- symptoms score
- medication score
- quality of life
- immunologic test from blood
Read the detailed description
Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for
- 2 months
- 6 months
- 12 months
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Intervention, Control
- Keywords
- Allergic rhinitis, Allergen injection immunotherapy, Efficacy
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBiological
Also called Mite allergen extract (D.p) from ALK company. 10,000 AU/ml
Dermatophagoides pteronyssinus from ALK company
ControlOther
Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | injection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid) Receives: Biological: Intervention |
| Control Group | Other | Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptoms score
3 point scale (0,1,2,3) and combination of
- nasal block
- rhinorrhea
- itching
- sneezing
Measured: average within 1 week
Secondary outcomes (1)
Combined total symptoms score and medication score
Total symptom score (nasal block, rhinorrhea, itching, sneezing, and eye symptoms with chest symptoms = Maximal score --> 18 devided by 6 = 3) PLUS medication score ( antihistamine = 1, topical nasal steroid = 2; --> Maximal score = 3).
Measured: average within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pongsakorn Tantilipikorn
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Sponsor-investigator, Pongsakorn Tantilipikorn, Mahidol University
- Investigators
- Pongsakorn Tantilipikorn, M.D., Principal investigator, Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115595
- Sponsor's protocol ID
- 336/2552
- Status last verified
- Mar 2019
- First submitted
- 1 May 2010
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mite Allergen Vaccine Among Thai Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01115595
- Acronym / sponsor ID
- 336/2552
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- Allergic rhinitis, Allergen injection immunotherapy, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pongsakorn TantilipikornUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Mar 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 May 2010 (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.
The purpose of this study is to study the efficacy of allergen injection immunotherapy for allergic rhinitis by
- symptoms score
- medication score
- quality of life
- immunologic test from blood
Detailed description
Compare the efficacy of allergen injection immunotherapy between the treatment group and the placebo group after injection for
- 2 months
- 6 months
- 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Biological: Interventioninjection by Mite extract with standard allergic medication (oral antihistamine and/or topical nasal steroid) |
| Control Group | Other | Other: ControlInjection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with the symptoms of allergic rhinitis who sensitized to mite (Dermatophagoides pteronyssinus)
- positive skin prick test to D.p. at 4+ degree
Key exclusion criteria (5 listed)
- steroid dependent asthma
- force expiratory volume (FEV1) less than 70% of predicted value
- previous injection immunotherapy within 2 years
- pregnancy
- medical conditions such as ischemic heart disease, autoimmune disease, cancer, previous history of anaphylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Mite allergen extract (D.p) from ALK company. 10,000 AU/mlDermatophagoides pteronyssinus from ALK company | Biological | Intervention |
| ControlInjection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid) | Other | Control Group |
Primary outcome
Total nasal symptoms score
Time frame: average within 1 week
3 point scale (0,1,2,3) and combination of * nasal block * rhinorrhea * itching * sneezing
1 secondary outcome
Combined total symptoms score and medication score
Time frame: average within 1 week
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 Mar 2019.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal 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.
Pongsakorn Tantilipikorn, M.D. principal investigator
Division of allergy and rhinology, Faculty of Medicine Siriraj, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention in people with Rhinitis, Allergic, Perennial, run by Pongsakorn Tantilipikorn 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 2 inclusion and 5 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 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total nasal symptoms score (time frame: average within 1 week). It is what the study was designed to measure, not a finding.
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 18 Mar 2019.