Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

Phase 3

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Depiquick Birch (DPG103); Drug: Placebo

• Registration Number: NCT01902992
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2012-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-19
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Depiquick® Birch	Depiquick Birch (DPG103)	At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.
Placebo	Placebo	At the screening visit (Visit 1), patients will be instructed how to complete the eDiary. Eligible patients will return for visit 2 as soon as they experience significant allergic symptoms. Significant allergic symptoms are defined by a symptom score ≥ 2. If the patients' eligibility has been confirmed according to inclusion/exclusion criteria checklist, randomization to one of the 2 treatment arms will be conducted. Patients will receive two consecutive subcutaneous injections of study medication (0,2 and 0,3 ml) with a time lag of ≥ 30 minutes. Patients return to the study site in weekly intervals for visit 3, visit 4, visit 5, visit 6, and visit 7 to receive study medication injections (0,5 ml each). If treatment is completed before the end of the tree pollen season, patients will be followed-up by telephone calls every 4 weeks until the end of the tree pollen season. The study completion visit will take place 4 weeks after the end of the tree pollen season.

Primary Outcome Measures

Name	Time	Method
Combined Symptom and Medication Score (SMS)	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 Outcome Measures

Name	Time	Method
Combined Symptom and Medication Score (SMS)	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
Onset of action (patient's assessment)	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".
Rhinoconjunctivitis Quality of Life questionnaire (RQLQ)	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).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Witten, Germany