RhinoconjunctivitisPhase 3NCT00550550
Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)
A Phase 3 study testing SCH 697243, Loratadine Syrup 1 mg/mL Rescue Treatment and Loratadine 10 mg Rescue Treatment in people with Rhinoconjunctivitis and Rhinitis, run by ALK-Abelló A/S.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis
- What is being tested?
- SCH 697243, Loratadine Syrup 1 mg/mL Rescue Treatment and Loratadine 10 mg Rescue Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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;
- 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.
Who cannot join
- 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.
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- 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.
- Female participants who are breast-feeding, pregnant, or intending to become pregnant.
- Participant who has had previous treatment by immunotherapy with grass pollen allergen or any other allergen within the 5 years prior to the Screening Visit.
- Participant with a known history of allergy, hypersensitivity or intolerance to the ingredients of the IMP (except for Phleum pratense), rescue medications, or self-injectable epinephrine.
- Participant 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.
- Participant who has used any investigational drugs within 30 days of the Screening Visit.
- Participant who is participating in any other clinical study.
- Participant who is a family member of the investigational study staff conducting this study.
- Participant who is unable to meet medication washout requirements as listed in the protocol.
- Participant who is unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the GPS, which in the opinion of the investigator will compromise the data.
- Participant with a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study.
- A participant participating in this study may not participate in this same study at another investigational site.
- A participant must not be randomized into this study more than once.
- Participant who is unable to or will not comply with the use of self-injectable epinephrine.
- Participants who may be at greater risk of developing adverse reactions after epinephrine administration.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
- Being tested
- Placebo, SCH 697243, Loratadine Syrup 1 mg/mL Rescue Treatment, Loratadine 10 mg Rescue Treatment, Olopatadine 0.1% Rescue Treatment
- Keywords
- rhinoconjunctivitis, rhinitis, conjunctivitis, allergy, allergen, immunotherapy
- Medical subject headings
- Rhinitis, Conjunctivitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo sublingual tablet, once daily
SCH 697243Biological
Also called Phleum pratense extract
Grass sublingual tablet, once daily
Loratadine Syrup 1 mg/mL Rescue TreatmentDrug
Also called Claritin
Loratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to <6 years of age and at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
Loratadine 10 mg Rescue TreatmentDrug
Also called Claritin
Loratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4.
Olopatadine 0.1% Rescue TreatmentDrug
Also called Pantanol
Olopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis.
Mometasone furoate 50 mcg Rescue TreatmentDrug
Also called Nasonex
Mometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to <12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to <18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray.
Albuterol 108 mcg Rescue TreatmentDrug
Also called Proventil, Ventolin, Volmax, Vospire
Albuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to <18 years with asthma symptoms .
Fluticasone 44 mcg Rescue TreatmentDrug
Also called Flonase
Fluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to <18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath.
Prednisone 5 mg Rescue TreatmentDrug
Also called Deltasone, Meticorten, Orasone, Prednicen-M
Prednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo; Drug: Loratadine Syrup 1 mg/mL Rescue Treatment; Drug: Loratadine 10 mg Rescue Treatment; Drug: Olopatadine 0.1% Rescue Treatment; Drug: Mometasone furoate 50 mcg Rescue Treatment; Drug: Albuterol 108 mcg Rescue Treatment; Drug: Fluticasone 44 mcg Rescue Treatment; Drug: Prednisone 5 mg Rescue Treatment |
| SCH 697243 | Experimental | Grass Sublingual Tablet (Phleum pratense extract) Receives: Biological: SCH 697243; Drug: Loratadine Syrup 1 mg/mL Rescue Treatment; Drug: Loratadine 10 mg Rescue Treatment; Drug: Olopatadine 0.1% Rescue Treatment; Drug: Mometasone furoate 50 mcg Rescue Treatment; Drug: Albuterol 108 mcg Rescue Treatment; Drug: Fluticasone 44 mcg Rescue Treatment; Drug: Prednisone 5 mg Rescue Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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.
Measured: From the Start of the GPS to the End of the GPS
Secondary outcomes (3)
Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).
Measured: Start of the GPS to the End of the GPS
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.
Measured: 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
The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.
Measured: Start of the GPS to the End of the GPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550550
- Sponsor's protocol ID
- P05239
- Other IDs
- 3733251
- Status last verified
- Jan 2017
- First submitted
- 29 Oct 2007
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011 Jan;127(1):64-71, 71.e1-4. doi: 10.1016/j.jaci.2010.11.034.
PubMed 21211642Hebert 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.
PubMed 25685162
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00550550
- Acronym / sponsor ID
- P05239
- Conditions
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
- Keywords
- rhinoconjunctivitis, rhinitis, conjunctivitis, allergy, allergen, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Posted 7 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: Loratadine Syrup 1 mg/mL Rescue Treatment, Drug: Loratadine 10 mg Rescue Treatment, Drug: Olopatadine 0.1% Rescue Treatment, Drug: Mometasone furoate 50 mcg Rescue Treatment, Drug: Albuterol 108 mcg Rescue Treatment, Drug: Fluticasone 44 mcg Rescue Treatment, Drug: Prednisone 5 mg Rescue TreatmentMatching Placebo |
| SCH 697243 | Experimental | Biological: SCH 697243, Drug: Loratadine Syrup 1 mg/mL Rescue Treatment, Drug: Loratadine 10 mg Rescue Treatment, Drug: Olopatadine 0.1% Rescue Treatment, Drug: Mometasone furoate 50 mcg Rescue Treatment, Drug: Albuterol 108 mcg Rescue Treatment, Drug: Fluticasone 44 mcg Rescue Treatment, Drug: Prednisone 5 mg Rescue TreatmentGrass Sublingual Tablet (Phleum pratense extract) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo sublingual tablet, once daily | Drug | Placebo |
| SCH 697243Also: Phleum pratense extractGrass sublingual tablet, once daily | Biological | SCH 697243 |
| Loratadine Syrup 1 mg/mL Rescue TreatmentAlso: ClaritinLoratadine Syrup 1 mg/mL was dosed orally once daily at a dose of 5 mg for children aged 5 to <6 years of age and at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. | Drug | Placebo, SCH 697243 |
| Loratadine 10 mg Rescue TreatmentAlso: ClaritinLoratadine 10 mg RediTabs tablets were dosed orally once daily at a dose of 10 mg for children aged 6 to <18 years of age as rescue medication for symptoms of rhinoconjunctivitis among participants with a total symptom score ≥4. | Drug | Placebo, SCH 697243 |
| Olopatadine 0.1% Rescue TreatmentAlso: PantanolOlopatadine hydrochloride 0.1% ophthalmic solution was dosed intraocularly at a dose of 1 drop in each affected eye twice daily, in addition to loratadine, as rescue medication for participants with persistent eye symptoms due to rhinoconjunctivitis. | Drug | Placebo, SCH 697243 |
| Mometasone furoate 50 mcg Rescue TreatmentAlso: NasonexMometasone furoate monohydrate nasal spray 50 mcg was dosed intranasally at a dose of one spray in each nostril once daily for participants aged 5 to <12 years and a dose of 2 sprays in each nostril once daily for participants aged 12 to <18 years as rescue medication for nasal symptoms of rhinoconjunctivitis among participants with a total symptom score of ≥4 despite loratadine and mometasone furoate nasal spray. | Drug | Placebo, SCH 697243 |
| Albuterol 108 mcg Rescue TreatmentAlso: Proventil, Ventolin, Volmax, VospireAlbuterol sulfate inhalation aerosol 108 mcg/inhalation was administered via inhalation at a dose of 2 inhalations every 4 to 6 hours as rescue medication among participants aged 5 to <18 years with asthma symptoms . | Drug | Placebo, SCH 697243 |
| Fluticasone 44 mcg Rescue TreatmentAlso: FlonaseFluticasone propionate inhalation aerosol 44 mcg/inhalation was administered via inhalation at a dose of 2 inhalations twice daily among participants aged 12 to <18 years up to a maximum dose of 10 inhalations twice daily, in combination with albuterol, among participants with ≥4 albuterol sulfate inhalations/day for 2 days as rescue medication for nocturnal asthma or shortness of breath. | Drug | Placebo, SCH 697243 |
| Prednisone 5 mg Rescue TreatmentAlso: Deltasone, Meticorten, Orasone, Prednicen-MPrednisone tablet 5 mg was administered orally at a dose of 1 mg/kg/day once daily up to a maximum of 50 mg/day on Day 1, and at a dose of 0.5 mg/kg/day once daily up to a maximum of 25 mg/day on Days 2, 3, 5, and 7 as rescue medication for asthma exacerbation at the discretion of the investigator. | Drug | Placebo, SCH 697243 |
Primary outcome
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.
3 secondary outcomes
Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
Time frame: Start of the GPS to the End of the GPS
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
Time frame: 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
Time frame: Start of the GPS to the End of the GPS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21211642Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol. 2011 Jan;127(1):64-71, 71.e1-4. doi: 10.1016/j.jaci.2010.11.034.
- Derived from this study: PubMed 25685162Hebert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SCH 697243, Loratadine Syrup 1 mg/mL Rescue Treatment and Loratadine 10 mg Rescue Treatment in people with Rhinoconjunctivitis and Rhinitis, run by ALK-Abelló A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00550550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.