Efficacy and Safety of Birch Pollen Immunotherapy in Loca... | NCT03157505

Studies
Efficacy and Safety of Birch Pollen Immunotherapy in Local Allergic Rhinitis

NCT03157505

Sponsor

Medical University of Silesia

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

78Actual

Phase

Phase 3

Conditions

Allergic Rhinitis
Allergic Reaction

Interventions

Purethal Birch immunotherapy
Placebo and symptomatic treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2014Actual

Primary Completion Date

Dec 30, 2016Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2017

Last Update Posted Date

May 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrzej Bozek, MD PhD, Medical University of SilesiaPrincipal Investigator

Lead Sponsor

Medical University of SilesiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Local allergic rhinitis (LAR) is relatively new disease. The question of effect of allergen specific immunotherapy on LAR is open. The randomized, double blind placebo controlled trial of birch subcutaneous AIT on LAR were performed in twenty eight patients. The therapy was performed during 24 months in proportion 15 patients with AIT and 13 placebo. The primary endpoint was decreased of symptoms medication score (SMS). Additionally monitoring serum specific IgE, specific IgG4 and nasal specific IgE (nsIgE) to Bet v1 and parameters of safety and quality of life were provided.

Detailed Description

Local allergic rhinitis (LAR) is still an under diagnosed and under treated disease. It is characterised by local production of IgE during natural exposure to aeroallergens. These patients have negative skin prick tests and serum-specific IgEs but have positive nasal provocation tests for aeroallergens. More than 50% of patients with chronic non-allergic rhinitis may have a problem with lack of LAR diagnosis. Misdiagnosis can lead to mistakes in the treatment as well as inefficiencies.

Besides on only local IgE-mediated reaction, allergen immunotherapy (AIT) could be a potential way of treatment such patients. However, there are only sufficient data that the AIT is effective in allergic rhinoconjunctivitis and asthma to pollens and house dust mites and some animal.

The aim of this study was to assess the safety and efficacy of AIT for birch pollen allergens in patients with local allergic rhinitis and a confirmed birch pollen allergy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Purethal Birch immunotherapy	Active Comparator	Purethat Birch intervention and symptomatic treatment for 24 months	Drug: Purethal Birch immunotherapy
placebo and symptomatic treatment	Placebo Comparator	placebo intervention and symtomatic treatment during 24 months	Other: Placebo and symptomatic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Purethal Birch immunotherapy	Drug	Purethal birch was administered as perennial therapy: 24 months	Purethal Birch immunotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area under the curve (AUC)	area under the curve (AUC) for the combined symptom and medication scores (SMS)	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

well document symptoms of rhinitis during birch pollen season
positive nasal provocation test to birch
negative results of skin prick tests to inhalant allergen including: D. pteronyssius, D. farinae, grass pollen, birch, hazel, alder Alternaria, and cat.
negative results of serum total and allergen specific IgE against mentioned allergens.

Exclusion Criteria:

diagnosis of bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases. All subjects were required to abstain from anti-allergy drugs and glucocorticoid nasal drops for at least 6 weeks prior to the start of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Fisher	Outpatient Clinic Allergy	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17337294	Background	Rondon C, Romero JJ, Lopez S, Antunez C, Martin-Casanez E, Torres MJ, Mayorga C, R-Pena R, Blanca M. Local IgE production and positive nasal provocation test in patients with persistent nonallergic rhinitis. J Allergy Clin Immunol. 2007 Apr;119(4):899-905. doi: 10.1016/j.jaci.2007.01.006. Epub 2007 Mar 2.
29273130	Derived

ID	Term
D065631	Rhinitis, Allergic
D006967	Hypersensitivity

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity