Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

NCT00562159 | Completed Phase 3 Results DMC

• 2 other identifiers: P052383727105
• Study Type: interventional
• Target: 439
• Locations: 0 countries
• Sites: N/A

Brief Summary

This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.

Conditions

Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy

Keywords

rhinoconjunctivitis; rhinitis; conjunctivitis; allergy; allergen; immunotherapy

Outcome Measures

Primary Outcomes (1)

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

  Start of the GPS to End of the GPS

Secondary Outcomes (3)

• Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo; Drug: Loratadine 10 mg Rescue Treatment; Drug: Olopatadine 0.1% Rescue Treatment; Drug: Mometasone 50 mcg Rescue Treatment; Drug: Prednisone 5 mg Rescue Treatment; Drug: Albuterol sulfate 108 mcg; Drug: Fluticasone propionate 44 mcg; Drug: Prednisone 5 mg

SCH 697243

EXPERIMENTAL

Biological: SCH 697243; Drug: Loratadine 10 mg Rescue Treatment; Drug: Olopatadine 0.1% Rescue Treatment; Drug: Mometasone 50 mcg Rescue Treatment; Drug: Prednisone 5 mg Rescue Treatment; Drug: Albuterol sulfate 108 mcg; Drug: Fluticasone propionate 44 mcg; Drug: Prednisone 5 mg

Interventions

Placebo DRUG

Placebo sublingual tablet

Placebo

SCH 697243 BIOLOGICAL

SCH 697243 (2800 Bioequivalent Allergen Units \[BAU\] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.

Also known as: Phleum pratense extract

SCH 697243

Loratadine 10 mg Rescue Treatment DRUG

Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.

Also known as: Claritin

Placebo; SCH 697243

Olopatadine 0.1% Rescue Treatment DRUG

Olopatadine hydrochloride 0.1% ophthalmic solution was administered intraocularly at a dose of 1 drop in each affected eye twice daily as rescue medication for rhinoconjunctivitis, as needed.

Also known as: Pantanol

Placebo; SCH 697243

Mometasone 50 mcg Rescue Treatment DRUG

Mometasone furoate monohydrate nasal spray 50 mcg was admininstered intranasally at a dose of 2 sprays in each nostril once daily as rescue medication for rhinoconjunctivitis, as needed.

Also known as: Nasonex

Placebo; SCH 697243

Prednisone 5 mg Rescue Treatment DRUG

Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for rhinoconjunctivitis among participants with a total symptom score of ≥ 4 despite treatment with loratadine and mometasone furoate nasal spray.

Also known as: Deltasone, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS

Placebo; SCH 697243

Albuterol sulfate 108 mcg DRUG

Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administed via inhalation at a dose of 2 inhalations every 4 to 6 hours, as needed, as rescue medication for asthma.

Also known as: Proventil, Ventolin, Volmax, Vospire

Placebo; SCH 697243

Fluticasone propionate 44 mcg DRUG

Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of two inhalations twice daily, to a maximum dose of 10 inhalations twice daily, as rescue medication for asthma among participants utilizing four or more albuterol sulfate inhalations/day for 2 days for nocturnal asthma or shortness of breath.

Also known as: Flonase

Placebo; SCH 697243

Prednisone 5 mg DRUG

Prednisone 5 mg tablets were administered orally at a dose of 1 mg/kg/day (maximum 50 mg/day) on Day 1 and 0.5 mg/kg/day (maximum 25 mg/day) on Days 2, 3, 5 and 7 as rescue medication for asthma at the discretion of the investigator for the treatment of asthma exacerbation.

Also known as: Deltasone, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS

Placebo; SCH 697243

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• medically prescribed topically-applied transdermal contraceptive patch;
• double-barrier method (eg, condom in combination with a spermicide); vasectomy and tubal ligation should each be considered as single barrier.
• Female participants of childbearing potential should be counseled in the appropriate use of birth control while in the study. Female participants who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.
• Female participants of childbearing potential must have a negative urine pregnancy test at the Screening Visit in order to be considered eligible for enrollment.

You may not qualify if:

• 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.
• Female participants who are breast-feeding, pregnant, or intending to become pregnant.
• Participatns who have had previous treatment by immunotherapy with grass pollen allergen or any other allergen within the 5 years prior to the Screening Visit.
• Participants with a known history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (except for Phleum pratense), rescue medications, or self-injectable epinephrine.
• Participants with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. Specific examples include but are not limited to hypertension being treated with beta blockers, coronary artery disease, arrhythmia, stroke, ocular conditions requiring topical beta blockers, any condition requiring the use of beta blockers.
• Participants that have used any investigational drugs within 30 days of the Screening Visit.

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Related Publications (2)

• Nelson HS, Nolte H, Creticos P, Maloney J, Wu J, Bernstein DI. Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. J Allergy Clin Immunol. 2011 Jan;127(1):72-80, 80.e1-2. doi: 10.1016/j.jaci.2010.11.035.

  PMID: 21211643 RESULT

• Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.

  PMID: 25685162 DERIVED

MeSH Terms

Conditions

Rhinitis; Conjunctivitis; Hypersensitivity

Interventions

Loratadine; Olopatadine Hydrochloride; Mometasone Furoate; Prednisone; Albuterol; Fluticasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Conjunctival Diseases; Eye Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 3, 2017
• Results First Posted: September 7, 2012

Record last verified: 2017-01