Allergic RhinitisSLITNCT01506843
Sublingual Immunotherapy in Children With Allergic Rhinitis
A study of Allergic Rhinitis, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Allergic Rhinitis
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Apr 2011
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of allergic rhinitis
- Positive skin test to Dermatophagoides pteronyssinus total extract
- Positive serum levels of specific IgE to D. pteronyssinus extract
Who cannot join
- Previous allergen immunotherapy
- Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
- Long term use of systemic corticosteroid.
- Airway infection 30 days prior to the selection.
- Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
- Users of cigarette smoke
- Presence of severe skin lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil
The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.
Read the detailed description
Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.
- Conditions
- Allergic Rhinitis
- Being tested
- Mite, Mite and Bacterial or Placebo
- Keywords
- IgA antibody, IgE antibody, IgG1/IgG4 subclasses, Mite allergy, Sublingual immunotherapy, Saliva
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mite, Mite and Bacterial or PlaceboBiological
Also called mite allergen extract, bacterial allergen extract
All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| mite allergen drop | Active comparator | Children with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo. Receives: Biological: Mite, Mite and Bacterial or Placebo |
| mite plus bacterial extracts | Active comparator | Vaccine constituted with mite and bacterial extracts will be compared to placebo. Receives: Biological: Mite, Mite and Bacterial or Placebo |
| Placebo | Placebo comparator | Placebo will be constituted by the same solution used to make dilution of the allergen extracts. Receives: Biological: Mite, Mite and Bacterial or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symptom and Medication Scores at 12 months
For clinical evaluation will be used a questionnaire determining the symptom and medication scores.
Measured: Baseline and 12 months
Secondary outcomes (1)
Change from Baseline in Specific Antibody Levels.
Measurement of serum specific antibodies (IgE, IgG1, IgG4, and IgA) to Dermatophagoides pteronyssinus total extract, and Der p 1 and Der p 2 allergens.
Measured: Baseline, 12 months and 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionApr 2011
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.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Ernesto Akio Taketomi, Federal University of Uberlandia
- Investigators
- Ernesto A Taketomi, MD, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506843
- Sponsor's protocol ID
- F3046
- Other IDs
- CNPq
- Acronym
- SLIT
- Status last verified
- Aug 2007
- First submitted
- 20 Dec 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil
- ClinicalTrials.gov ID
- NCT01506843
- Acronym / sponsor ID
- SLIT / F3046
- Conditions
- Allergic Rhinitis
- Keywords
- IgA antibody, IgE antibody, IgG1/IgG4 subclasses, Mite allergy, Sublingual immunotherapy, Saliva
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 10 Jan 2012 (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 evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.
Detailed description
Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mite allergen drop | Active comparator | Biological: Mite, Mite and Bacterial or PlaceboChildren with allergic rhinitis sensitized with dust mites will receive progressive doses of allergen drops comparing those receiving placebo. |
| mite plus bacterial extracts | Active comparator | Biological: Mite, Mite and Bacterial or PlaceboVaccine constituted with mite and bacterial extracts will be compared to placebo. |
| Placebo | Placebo comparator | Biological: Mite, Mite and Bacterial or PlaceboPlacebo will be constituted by the same solution used to make dilution of the allergen extracts. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of allergic rhinitis
- Positive skin test to Dermatophagoides pteronyssinus total extract
- Positive serum levels of specific IgE to D. pteronyssinus extract
Key exclusion criteria (7 listed)
- Previous allergen immunotherapy
- Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
- Long term use of systemic corticosteroid.
- Airway infection 30 days prior to the selection.
- Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
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 |
|---|---|---|
| Mite, Mite and Bacterial or PlaceboAlso: mite allergen extract, bacterial allergen extractAll treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy | Biological | Placebo, mite allergen drop, mite plus bacterial extracts |
Primary outcome
Change from Baseline in Symptom and Medication Scores at 12 months
Time frame: Baseline and 12 months
For clinical evaluation will be used a questionnaire determining the symptom and medication scores.
1 secondary outcome
Change from Baseline in Specific Antibody Levels.
Time frame: Baseline, 12 months and 18 Months
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 10 Jan 2012.
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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.
Ernesto A Taketomi, MD, PhD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Allergic Rhinitis, run by Federal University of Uberlandia at 1 site in Brazil.
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 3 inclusion and 7 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 10 Jan 2012. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline in Symptom and Medication Scores at 12 months (time frame: Baseline and 12 months). 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 10 Jan 2012.