Allergic RhinitisNCT01247259
Efficacy of Sublingual Immunotherapy in Polysensitized Allergic Rhinitis Patients
A study testing Pangramin® in people with Allergic Rhinitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. Read more about this study
- Who is it for?
- Ages 4 to 53 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Pangramin®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to Oct 2010
- Phase
- Interventional
- 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 4 to 53 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms
- patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df), as confirmed by skin prick testing (A/H ratio ≥ 1) or MAST
Who cannot join
- Patients who had immunotherapy in the preceding 3 years
- Patients who had systemic immunological disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Otorhinolaryngology, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients
Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. This study compared the efficacy of SLIT with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients.
Patients who were sensitized to house dust mites and treated with SLIT for house dust mites for at least 1 year between November 2007 and March 2010 were included. The mono-allergen sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy. Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.
Read more
This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups, while the change in the TNSS did not differ significantly between the groups. The anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups.
In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized allergic rhinitis patients.
- Conditions
- Allergic Rhinitis
- Being tested
- Pangramin®
- Keywords
- allergic rhinitis, immunotherapy, sublingual
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pangramin®Drug
During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| SLIT-mono | Active comparator | Not described Receives: Drug: Pangramin® |
| SLIT-poly | Active comparator | Not described Receives: Drug: Pangramin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
total nasal symptom score (TNSS) and anti-allergic medication score (AMS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startNov 2007
- Primary completionFeb 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dong-Young Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247259
- Sponsor's protocol ID
- SLIT-POLYSENSITIZATION
- Status last verified
- Nov 2010
- First submitted
- 18 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sublingual Immunotherapy With House Dust Mite Extract in Poly-allergen-sensitized Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT01247259
- Acronym / sponsor ID
- SLIT-POLYSENSITIZATION
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, immunotherapy, sublingual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Nov 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.
Recently, interest has increased in sublingual immunotherapy (SLIT) for treating allergic rhinitis. It is often suggested that polysensitized patients might not benefit from specific immunotherapy as much as monosensitized patients, although further research on this subject is needed. This study compared the efficacy of SLIT with standardized house dust mite extract in mono- and polysensitized allergic rhinitis patients.
Patients who were sensitized to house dust mites and treated with SLIT for house dust mites for at least 1 year between November 2007 and March 2010 were included. The mono-allergen sensitized group (Mgr) was defined as the patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df; n = 70). The poly-allergen sensitized group (Pgr) was defined as the patients who were simultaneously sensitized to house dust mites and other allergens (n = 64). A standardized extract of house dust mites was used for immunotherapy. Anti-allergic medication and the total nasal symptom score (TNSS), including rhinorrhea, sneezing, nasal obstruction, and itchy nose, were evaluated before and 1 year after SLIT.
This study enrolled 134 patients. The TNSS improved significantly after SLIT in both groups, while the change in the TNSS did not differ significantly between the groups. The anti-allergic medication scores also decreased significantly in both groups, but there was no significant difference between the groups.
In polysensitized allergic rhinitis patients, SLIT for Dp/Df gave comparable improvements in both nasal symptoms and rescue medication scores to those in monosensitized patients, regardless of other positive allergens. SLIT for Dp/Df might be considered in polysensitized allergic rhinitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLIT-mono | Active comparator | Drug: Pangramin® |
| SLIT-poly | Active comparator | Drug: Pangramin® |
Who may qualify
- Ages
- 4 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients who had sneezing, itching, rhinorrhea, and nasal congestion with or without eye symptoms
- patients who were sensitized to Dermatophagoides pteronyssinus (Dp) or D. farinae (Df), as confirmed by skin prick testing (A/H ratio ≥ 1) or MAST
Key exclusion criteria (2 listed)
- Patients who had immunotherapy in the preceding 3 years
- Patients who had systemic immunological disorders
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 |
|---|---|---|
| Pangramin®During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase. | Drug | SLIT-mono, SLIT-poly |
Primary outcome
total nasal symptom score (TNSS) and anti-allergic medication score (AMS)
Time frame: 1 year
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 24 Nov 2010.
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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.
Dong-Young Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pangramin® in people with Allergic Rhinitis, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 24 Nov 2010. 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 South Korea. 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?
total nasal symptom score (TNSS) and anti-allergic medication score (AMS) (time frame: 1 year). 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 24 Nov 2010.