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Completed

NCT Number: NCT01902992

Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must experience significant allergic symptoms on visit 2
  • Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
  • Specific IgE against birch allergens (CAP RAST ≥ 2)

Exclusion criteria

  • History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
  • FEV1 or PEF value ≤ 80 %
  • Persistent asthma (GINA ≥ 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Depiquick Birch (DPG103)

Drug

Placebo

Drug

Primary outcomes

  1. Combined Symptom and Medication Score (SMS)

    Time frame: From the start of treatment until the end of the relevant pollen exposition time.

    The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The rescue medication score is defined as the mean of the daily rescue medication scores during the pollen season. A lower score indicates an improvement in the allergic condition. Minimum score of the SMS is "0", maximum score is dependent on intake of rescue medication.

Secondary outcomes

  1. Combined Symptom and Medication Score (SMS)

    Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months

    The SMS represents the sum of the mean daily symptom severity score plus the mean daily rescue medication score. The symptom severity score is defined as the mean of the daily symptom severity scores during the pollen season. The overall severity rhinitis/rhinoconjunctivitis (including nasal itching, sneezing, rhinorrhea, nasal obstruction, ocular itching/grittiness/redness, and ocular tearing) and asthma (including chest tightness, shortness of breath, cough, wheezing) will be evaluated by the patient daily

  2. Onset of action (patient's assessment)

    Time frame: date of randomization until 4 weeks after the end of the birch pollen season 2012, assessed up to 5 months

    Patients will document the point in time when they experience onset of action of the therapy by answering the question "Do you have the feeling that your allergy symptoms are better or less due to SIT today?" with "Yes" or "No".

  3. Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)

    Time frame: Visits 2, 4, 6, and 7

    The RQLQ is a 28-item disease specific questionnaire designed to measure functional impairments that are most important to patients with rhinitis/rhinoconjunctivitis (Juniper and Guyatt 1991). It consists of 7 domains (activities, sleep, common complaints, practical problems, nasal symptoms, ocular symptoms, and emotions).

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Intraseasonal Specific Short-term Immunotherapy With Depigmented Glutaraldehyde Polymerized Birch Pollen Allergenic Extract (Depiquick® Birch) in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma

Acronym: INSIDE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2013
Registry last updated
Mar 22, 2017

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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