A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Rhinoconjunctivitis
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 439
- Primary Endpoint
- Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
Detailed Description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in participants 18 to 65 years of age, 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 hinoconjunctivitis 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. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must be 18 to 65 years of age, of either sex, and of any race.
- •Participants 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.
- •Participants 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.
- •Participants must be positive for specific IgE against Phleum pratense (\>=IgE Class 2) at the Screening Visit.
- •Participants must have an FEV1 \>=70% of predicted value at the Screening Visit.
- •Participants' safety laboratory tests, vital signs and ECG conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor.
- •Participant must be willing to give written informed consent 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
- •Participants 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.
- •Participants with a clinical history of significant symptomatic perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed.
- •Participants with sufficient pre-seasonal data in the observational phase will not be eligible to continue in the treatment phase if the subject: 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.
- •Participants that received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
- •Participants with a clinical history of severe asthma.
- •Participants with history of anaphylaxis with cardiorespiratory symptoms.
- •Participants with a history of self-injectable epinephrine use.
- •Participants with a history of chronic urticaria and angioedema.
- •Participants with clinical history of chronic sinusitis during the 2 years prior to the Screening Visit.
- •Participants with current severe atopic dermatitis.
Arms & Interventions
Placebo
Matching Placebo
Intervention: Placebo
Placebo
Matching Placebo
Intervention: Loratadine 10 mg Rescue Treatment
Placebo
Matching Placebo
Intervention: Olopatadine 0.1% Rescue Treatment
Placebo
Matching Placebo
Intervention: Mometasone 50 mcg Rescue Treatment
Placebo
Matching Placebo
Intervention: Prednisone 5 mg Rescue Treatment
Placebo
Matching Placebo
Intervention: Albuterol sulfate 108 mcg
Placebo
Matching Placebo
Intervention: Fluticasone propionate 44 mcg
Placebo
Matching Placebo
Intervention: Prednisone 5 mg
SCH 697243
Intervention: SCH 697243
SCH 697243
Intervention: Loratadine 10 mg Rescue Treatment
SCH 697243
Intervention: Olopatadine 0.1% Rescue Treatment
SCH 697243
Intervention: Mometasone 50 mcg Rescue Treatment
SCH 697243
Intervention: Prednisone 5 mg Rescue Treatment
SCH 697243
Intervention: Albuterol sulfate 108 mcg
SCH 697243
Intervention: Fluticasone propionate 44 mcg
SCH 697243
Intervention: Prednisone 5 mg
Outcomes
Primary Outcomes
Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
Time Frame: Start of the GPS to 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 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, 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 0-36, with a lower score indicating less use of rescue medication.
Secondary Outcomes
- Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS(Start of the GPS to End of the GPS)
- Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS(Start of the GPS to End of the GPS)
- Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS(Start of the GPS to End of the GPS)