The Effects of Immunotherapy in the Nose

NCT01985542 | Completed Results

• 1 other identifier: The effects of immunotherapy
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Allergic rhinitis might be caused by decreased resistance of nasal barrier to allergens and other environmental insults. About 20 % of the European population suffers from pollen allergies. Birch pollen allergic rhinitis is the most common allergic disease in the Scandinavia and it exists widely also in the Central Europe. Suffering and high costs of pollen allergies may be reduced by understanding the molecular biology of the nasal barriers during allergic response. Our aim is to observe the effect of season and birch pollen immunotherapy on the molecular biology of nasal epithelium and the microbiome.

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• The Total Number of Differentially Expressed Transcripts.

  Transcriptomics are evaluated By Next Generation Sequencing. The total number of differentially expressed transcripts are defined from nasal epithelial brushing samples taken at -6 months vs. at +6 months in the two subject groups. The subject groups are the Subcutaneous immunotherapy group and No immunotherapy group.

  -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

Secondary Outcomes (1)

• Percentage Change in Visual Analogue Scale Scores of Symptoms

  -6 months vs. +6 months from the starting point of birch pollen subcutaneous immunotherapy.

Study Arms (2)

subcutaneous immunotherapy

ACTIVE COMPARATOR

Starts with birch pollen subcutaneous immunotherapy

Drug: birch pollen subcutaneous immunotherapy

no immunotherapy

NO INTERVENTION

not starting with birch pollen subcutaneous immunotherapy

Interventions

birch pollen subcutaneous immunotherapy DRUG

birch pollen subcutaneous immunotherapy

subcutaneous immunotherapy

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• allergic rhinoconjunctivitis of birch pollen OR healthy controls

You may not qualify if:

• smoking, asthma, any other disease than allergic rhinoconjunctivitis, requiring constant medication

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• Finnish Institute of Occupational Health: collaborator

Related Publications (2)

• Mattila P, Renkonen J, Toppila-Salmi S, Parviainen V, Joenvaara S, Alff-Tuomala S, Nicorici D, Renkonen R. Time-series nasal epithelial transcriptomics during natural pollen exposure in healthy subjects and allergic patients. Allergy. 2010 Feb;65(2):175-83. doi: 10.1111/j.1398-9995.2009.02181.x. Epub 2009 Oct 5.

  PMID: 19804444 BACKGROUND

• Joenvaara S, Mattila P, Renkonen J, Makitie A, Toppila-Salmi S, Lehtonen M, Salmi P, Lehti S, Makinen J, Sormunen R, Paavonen T, Renkonen R. Caveolar transport through nasal epithelium of birch pollen allergen Bet v 1 in allergic patients. J Allergy Clin Immunol. 2009 Jul;124(1):135-142.e1-21. doi: 10.1016/j.jaci.2008.11.048. Epub 2009 Apr 2.

  PMID: 19344938 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Sanna Salmi
• Organization: Helsinki University Hospital

sanna.salmi@helsinki.fi

+358505431421

Study Officials

• Sanna K Salmi, MD PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Docent

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 15, 2013
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 10, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share