Pollen AllergyPhase 3NCT01500642
Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy
A Phase 3 study testing Slit One and Slit One ragweed in people with Pollen Allergy, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pollen Allergy
- What is being tested?
- Slit One and Slit One ragweed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Sep 2011
- Phase
- Phase 3
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-55 years
- Known allergy to ragweed pollen
- No immunotherapy or in progress prior to enrollment
- Symptoms of rhino / conjunctivitis with or without asthma
Who cannot join
- Allergic to perennial allergens (moulds, mites and animal when exposed to the animal)
- Patients with chronic diseases (infectious, autoimmune cancer, heart or kidney)
- Are pregnant
- Chronic drug treatment with steroids and / or immunosuppressive
- Oral disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy in Patients With Ragweed Pollinosis: a Phase III Randomized and Controlled Clinical Study
The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed
Read the detailed description
Version 1 16/02/2011 The allergen-specific immunotherapy represents an important therapeutic option for the treatment of allergic respiratory diseases. Its clinical efficacy is well demonstrated, although the mechanism of action is still under study.
The main purpose of immunotherapy is to induce an allergen-specific tolerance so that the natural exposure to the allergen does not cause clinical symptoms.
The clinical efficacy of standard subcutaneous immunotherapy (SCIT) is known. A meta-analysis Cochrane on the clinical efficacy of SCIT in allergic rhinitis 51 double-blind studies with a total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction in the use of drugs in 57%.
Other studies also show that SCIT was effective in the long term (at least 3-5 years of suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and the use of asthma medications.
Sublingual immunotherapy (SLIT) represents an effective alternative route of administration of vaccine therapy with an allergic profile security than the SCIT.
- Conditions
- Pollen Allergy
- Being tested
- Slit One, Slit One ragweed
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit OneBiological
Also called Slitone (Alk Abello)
slit one sublingual immunotherapy 200 stu
Slit OneBiological
Also called Slitone (Alk Abello)
slit one vestibular immunotherapy 200 stu
Slit One ragweedBiological
Also called Slitone (Alk Abello)
slit one 400 stu dose ragweed (sublingual doubled immunotherapy)
| Study group | Role | What they receive |
|---|---|---|
| sublingual immunotherapy | Active comparator | 15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 Receives: Biological: Slit One |
| vestibular immunotherapy | Active comparator | 15 patients treated with vestibular immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 Receives: Biological: Slit One |
| sublingual doubled immunotherapy | Active comparator | 15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at doubled dose (400 STU / dose) from June to August 2001 Receives: Biological: Slit One ragweed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific (ragweed) in pre-seasonal SLIT vs oral-vestibular regimen and in pre-seasonal regimen of SLIT at 400 STU/dose vs 200 STU
Measured: 3 months
Secondary outcomes (4)
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually
Measured: 3 months
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
Measured: 3 months
Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually
Measured: 3 months
Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pollen AllergyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Collaborators
- ALK-Abelló A/S
- Responsible party
- Principal investigator, Iemoli Enrico, ASST Fatebenefratelli Sacco
- Investigators
- enrico iemoli, phd, Principal investigator, luigi sacco hospital milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500642
- Sponsor's protocol ID
- 130/2011/29/AP
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy in Patients With Ragweed Pollinosis: a Phase III Randomized and Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01500642
- Acronym / sponsor ID
- 130/2011/29/AP
- Conditions
- Pollen Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Collaborators
- ALK-Abelló A/S
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Dec 2011 (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 dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed
Detailed description
Version 1 16/02/2011 The allergen-specific immunotherapy represents an important therapeutic option for the treatment of allergic respiratory diseases. Its clinical efficacy is well demonstrated, although the mechanism of action is still under study.
The main purpose of immunotherapy is to induce an allergen-specific tolerance so that the natural exposure to the allergen does not cause clinical symptoms.
The clinical efficacy of standard subcutaneous immunotherapy (SCIT) is known. A meta-analysis Cochrane on the clinical efficacy of SCIT in allergic rhinitis 51 double-blind studies with a total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction in the use of drugs in 57%.
Other studies also show that SCIT was effective in the long term (at least 3-5 years of suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and the use of asthma medications.
Sublingual immunotherapy (SLIT) represents an effective alternative route of administration of vaccine therapy with an allergic profile security than the SCIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sublingual immunotherapy | Active comparator | Biological: Slit One15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 |
| vestibular immunotherapy | Active comparator | Biological: Slit One15 patients treated with vestibular immunotherapy (SLIT One, ALK Abello) administered at standard dose (200 STU / dose) from June to August 2001 |
| sublingual doubled immunotherapy | Active comparator | Biological: Slit One ragweed15 patients treated with sublingual immunotherapy (SLIT One, ALK Abello) administered at doubled dose (400 STU / dose) from June to August 2001 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-55 years
- Known allergy to ragweed pollen
- No immunotherapy or in progress prior to enrollment
- Symptoms of rhino / conjunctivitis with or without asthma
Key exclusion criteria (5 listed)
- Allergic to perennial allergens (moulds, mites and animal when exposed to the animal)
- Patients with chronic diseases (infectious, autoimmune cancer, heart or kidney)
- Are pregnant
- Chronic drug treatment with steroids and / or immunosuppressive
- Oral disease
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 |
|---|---|---|
| Slit OneAlso: Slitone (Alk Abello)slit one sublingual immunotherapy 200 stu | Biological | sublingual immunotherapy |
| Slit OneAlso: Slitone (Alk Abello)slit one vestibular immunotherapy 200 stu | Biological | vestibular immunotherapy |
| Slit One ragweedAlso: Slitone (Alk Abello)slit one 400 stu dose ragweed (sublingual doubled immunotherapy) | Biological | sublingual doubled immunotherapy |
Primary outcome
To evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific (ragweed) in pre-seasonal SLIT vs oral-vestibular regimen and in pre-seasonal regimen of SLIT at 400 STU/dose vs 200 STU
Time frame: 3 months
4 secondary outcomes
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine by vestibular compared to those treated sublingually
Time frame: 3 months
Evaluation of clinical efficacy (as assessed by symptom score and use of symptomatic drugs) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
Time frame: 3 months
Evaluation of the safety and tolerability (as assessed by data collection form of local and systemic adverse events) among patients treated with sublingual vaccine in oral/vestibular administration compared to those treated sublingually
Time frame: 3 months
Assessment of safety and tolerability (assessed using data forms of local and systemic adverse events) among patients treated with sublingual vaccine dose doubled compared to those treated with standard dose
Time frame: 3 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 5 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.
enrico iemoli, phd principal investigator
luigi sacco hospital milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Slit One and Slit One ragweed in people with Pollen Allergy, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
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 4 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 5 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific (ragweed) in pre-seasonal SLIT vs oral-vestibular regimen and in pre-seasonal regimen of SLIT at 400 STU/dose vs 200 STU (time frame: 3 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 5 Jan 2012.