Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE

NCT00755066 | Completed

• 2 other identifiers: 2505EudraCT 2005-004274-24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal provocation and serum IgE levels will be followed during eight weeks after nasal provocation.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Allergen specific IgE levels

  8 weeks

Secondary Outcomes (1)

• Allergen specific IgG 1-4, IgM, IgA levels

  8 weeks

Study Arms (2)

F

EXPERIMENTAL

Fluticasone propionate 200 µg intranasal

Drug: Fluticasone propionate

P

PLACEBO COMPARATOR

Placebo intranasal spray

Drug: Placebo

Interventions

Fluticasone propionate DRUG

200 µg intranasal, 4 weeks, od.

F

Placebo DRUG

Placebo intranasal spray

P

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male or female 18-50 years of age
• moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history
• sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter \>= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml
• willingness to comply with the study protocol
• written informed consent

You may not qualify if:

• perennial allergic rhinitis
• history of asthma necessitating treatment
• FEV1 \<70% of predicted value
• abnormalities at auscultation of heart or lungs
• history of anaphylaxis
• severe atopic dermatitis
• total serum IgE \>2000 kU/l
• previous or ongoing immunotherapy (subcutaneous or sublingual) to grass or birch pollen
• nasal provocation testing during the previous six month
• known allergy/intolerance to fluticasone propionate or loratadine
• known allergy/intolerance to cellulose, polysorbate, phenylethyl alcohol, benzalkonium chloride
• contraindications for the use of INCS:
• acute or chronic infections of the upper respiratory tract
• surgery of the nose during the previous year
• hypersensitivity to components of the drug

Sponsors & Collaborators

• Medical University of Vienna: lead
• Allergy Centre Vienna West: collaborator

Study Sites (1)

Allergy Centre Vienna West

Vienna, 1150, Austria

Location

Related Publications (1)

• Egger C, Lupinek C, Ristl R, Lemell P, Horak F, Zieglmayer P, Spitzauer S, Valenta R, Niederberger V. Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure. PLoS One. 2015 Feb 23;10(2):e0114991. doi: 10.1371/journal.pone.0114991. eCollection 2015.

  PMID: 25705889 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Friedrich Horak, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

AU (1)