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OpenTrials
Completed

NCT Number: NCT00396149

Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

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Key information

Conditions

Birch Pollen-Related Rhinoconjunctivitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National University Hospital - Allergy Unit 4222

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • written consent
  • Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
  • Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
  • FEV1 at least of 80% of predicted values at screening.

Exclusion criteria

  • Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder…) or who plan to start desensitization treatment during this study.

Treatment and study plan

Placebo

Biological

Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

rBet v 1

Biological

Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.

Other names: rBet v 1.0101

Primary outcomes

  1. Local tolerability

    Time frame: Assessed every day over 2 weeks

  2. Global safety

    Time frame: Assessed every day over 2 weeks

Secondary outcomes

  1. Immunological markers (IgE and IgG4)

    Time frame: Between selection and follow-up visit

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 6, 2006
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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