A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

ALK-Abelló A/S0 sites345 target enrollmentNovember 2007

ConditionsRhinoconjunctivitis Rhinitis Conjunctivitis Allergy

InterventionsPlacebo Loratadine Syrup 1 mg/mL Rescue Treatment Loratadine 10 mg Rescue Treatment Olopatadine 0.1% Rescue Treatment Mometasone furoate 50 mcg Rescue Treatment Albuterol 108 mcg Rescue Treatment Fluticasone 44 mcg Rescue Treatment Prednisone 5 mg Rescue Treatment SCH 697243

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Rhinoconjunctivitis
Sponsor: ALK-Abelló A/S
Enrollment: 345
Primary Endpoint: Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual tablet or placebo. Open-label rescue medications for the rhinoconjunctivitis and asthma symptoms will be provided. Participants will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6 rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the participant/parent/guardian. The start and end of the grass pollen season (GPS) was determined based on the regional grass pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m\^3, to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10 grains/m\^3, inclusively.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

September 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ALK-Abelló A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant must be 5 to \<18 years of age, of either sex, and of any race.
•Participant must have a clinical history of significant allergic rhinoconjunctivitis to grass (with or without asthma) diagnosed by a physician and have received treatment for their disease during the previous GPS.
•Participant must have a positive skin prick test response (average wheal diameter \>=5 mm larger than the saline control after 15 to 20 minutes) to Phleum pratense at the Screening Visit.
•Participant must have positive specific IgE against Phleum pratense (\>= IgE Class 2) at the Screening Visit.
•Participant must have an FEV1 \>=70% of predicted value at the Screening Visit.
•A participant's safety laboratory tests and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.
•A participant (and/or parent/guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must be willing to give written informed consent/assent and be able to adhere to dose and visit schedules.
•Female participants of childbearing potential must be using a medically acceptable and adequate form of birth control. These include:
•hormonal contraceptives as prescribed by a physician (oral, hormonal vaginal ring, hormonal implant or depot injectable);
•medically prescribed intra-uterine device;

Exclusion Criteria

•Participant with a clinical history of symptomatic seasonal allergic rhinitis and/or asthma, having received regular medications due to another allergen during or potentially overlapping the GPS.
•Participant with a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the participant is regularly exposed.
•Participant with sufficient pre-seasonal data in the observational phase will not be eligible to continue in the treatment phase if the participant: 1) does not experience an increase in rhinoconjunctivitis symptom score of equal to or greater than 4 above the pre-seasonal average symptom score for at least 2 days, 2) does not use allergy rescue medication for at least 2 days, during the observational phase Year 1 2008 GPS.
•Participant has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
•Participant with a clinical history of severe asthma.
•Participant with history of anaphylaxis with cardiorespiratory symptoms.
•Participant with history of self-injectable epinephrine use.
•Participant with a history of chronic urticaria and angioedema.
•Participant with clinical history of chronic sinusitis during the 2 years prior to the Screening Visit.
•Participant with current severe atopic dermatitis.

Intervention: Prednisone 5 mg Rescue Treatment

Outcomes

Primary Outcomes

Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)

Time Frame: From the Start of the GPS to the End of the GPS

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.

Secondary Outcomes

Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS(Start of the GPS to the End of the GPS)
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS(Start of the GPS to the End of the GPS)
Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS(Start of the GPS to the End of the GPS)