Comparison of efficacy and safety of different regimens of sublingual immunotherapy for Ragweed.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001682-41-IT

Enrollment

Registered

2011-12-06

Start date

2011-05-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects who are allergic to Ragweed. MedDRA version: 14.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders

Interventions

Product Name: Ragweed estract Pharmaceutical Form: Oral drops INN or Proposed INN: AMBROSIA ARTEMISIIFOLIA L. Concentration unit: SU Standardised Unit(s) (Deprecated) Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 18-55 years, known allergy to ragweed pollen, no immunotherapy or in progress prior to enrollement, symptoms of rhino/conjunctivitis with or without asthma. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergic to perennial allergens (moulds, mites and animal when exposed to the animal), patients with chronic diseases (infectious, autoimmune cancer, heart or kidney), pregnancy, chronic drug treatment with steroids and/or immunosuppressive drugs, oral diseases.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually vs oral-vestibular; Assess the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose.;Secondary Objective: 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; 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; 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; 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.;Primary end point(s): The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14-PDL-1-IL10 + outstanding of at least 25 percentile points.;Timepoint(s) of evaluation of this end point: At study termination (3 months).	—

Measure

Time frame

Main Objective: Evaluate the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually vs oral-vestibular; Assess the percentage of CD14-PDL-1-IL10 + circulating allergen-specific ragweed-allergic patients undergoing pre-seasonal regimen of SLIT administered sublingually at a dose doubled 400 STU/dose vaccine compared to the commonly used marketing 200 STU/dose.;Secondary Objective: 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; 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; 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; 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.;Primary end point(s): The end of the study will detect a difference between groups with respect to the primary objective, the percentage of CD14-PDL-1-IL10 + outstanding of at least 25 percentile points.;Timepoint(s) of evaluation of this end point: At study termination (3 months).

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Secondary

Measure	Time frame
Secondary end point(s): None.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Italy

Contacts

Public ContactS.S. Allergologia-Immunologia Clin.

Ospedale Luigi Sacco

iemoli.enrico@hsacco.it02-39043490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026