RhinoconjunctivitisPhase 3NCT00562159
Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)
A Phase 3 study testing SCH 697243, Loratadine 10 mg Rescue Treatment and Olopatadine 0.1% Rescue Treatment in people with Rhinoconjunctivitis and Rhinitis, run by ALK-Abelló A/S.
Trial summary
This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis
- What is being tested?
- SCH 697243, Loratadine 10 mg Rescue Treatment and Olopatadine 0.1% Rescue Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Participants that are participating in any other clinical study.
- Participants that are a family member of the investigational study staff conducting this study.
- Participants that are unable to meet medication washout requirements as listed in the protocol.
- Participants that are 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.
- Participants with a clinically significant abnormal vital sign or laboratory value that would preclude participation in the study.
- Participants participating in this study may not participate in this same study at another investigational site.
- Participants must not be randomized into this study more than once.
- Participants who are unable to or will not comply with the use of self-injectable epinephrine.
- Participants that may be at greater risk of developing adverse reactions after epinephrine administration.
About this study
Official title: 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
This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
Read the 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.
- Conditions
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
- Being tested
- Placebo, SCH 697243, Loratadine 10 mg Rescue Treatment, Olopatadine 0.1% Rescue Treatment, Mometasone 50 mcg 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
SCH 697243Biological
Also called Phleum pratense extract
SCH 697243 (2800 Bioequivalent Allergen Units [BAU] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily.
Loratadine 10 mg Rescue TreatmentDrug
Also called Claritin
Loratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS.
Olopatadine 0.1% Rescue TreatmentDrug
Also called Pantanol
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.
Mometasone 50 mcg Rescue TreatmentDrug
Also called Nasonex
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.
Prednisone 5 mg Rescue TreatmentDrug
Also called Deltasone, Meticorten, Orasone, Prednicen-M
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.
Albuterol sulfate 108 mcgDrug
Also called Proventil, Ventolin, Volmax, Vospire
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.
Fluticasone propionate 44 mcgDrug
Also called Flonase
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.
Prednisone 5 mgDrug
Also called Deltasone, Meticorten, Orasone, Prednicen-M
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching Placebo Receives: 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 | Not described Receives: 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 |
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 0-54, 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.
Measured: Start of the GPS to End of the GPS
Secondary outcomes (3)
Participant Average Rhinoconjunctivitis Daily Symptom Score (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 to 18.
Measured: Start of the GPS to 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 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.
Measured: 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
The RQLQ(s) 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 0-6, with a higher score indicating more significant impairment.
Measured: Start of the GPS to 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 posted21 Nov 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 439 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
- NCT00562159
- Sponsor's protocol ID
- P05238
- Other IDs
- 3727105
- Status last verified
- Jan 2017
- First submitted
- 20 Nov 2007
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21211643Hebert 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 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
- ClinicalTrials.gov ID
- NCT00562159
- Acronym / sponsor ID
- P05238
- Conditions
- Rhinoconjunctivitis, Rhinitis, Conjunctivitis, Allergy
- Keywords
- rhinoconjunctivitis, rhinitis, conjunctivitis, allergy, allergen, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 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
- 21 Nov 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | 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 mgMatching Placebo |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 | Drug | Placebo |
| SCH 697243Also: Phleum pratense extractSCH 697243 (2800 Bioequivalent Allergen Units [BAU] of Phleum pratense extract, containing approximately 15 mcg Phl p 5), administered sublingually once daily. | Biological | SCH 697243 |
| Loratadine 10 mg Rescue TreatmentAlso: ClaritinLoratadine 10 mg RediTabs tablets were dosed orally once daily as rescue medication among participants with a total symptom score ≥ 4 during the GPS. | Drug | Placebo, SCH 697243 |
| Olopatadine 0.1% Rescue TreatmentAlso: PantanolOlopatadine 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. | Drug | Placebo, SCH 697243 |
| Mometasone 50 mcg Rescue TreatmentAlso: NasonexMometasone 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. | Drug | Placebo, SCH 697243 |
| Prednisone 5 mg Rescue TreatmentAlso: Deltasone, Meticorten, Orasone, Prednicen-MPrednisone 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. | Drug | Placebo, SCH 697243 |
| Albuterol sulfate 108 mcgAlso: Proventil, Ventolin, Volmax, VospireAlbuterol 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. | Drug | Placebo, SCH 697243 |
| Fluticasone propionate 44 mcgAlso: FlonaseFluticasone 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. | Drug | Placebo, SCH 697243 |
| Prednisone 5 mgAlso: Deltasone, Meticorten, Orasone, Prednicen-MPrednisone 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. | Drug | Placebo, SCH 697243 |
Primary outcome
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.
3 secondary outcomes
Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS
Time frame: Start of the GPS to End of the GPS
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
Time frame: 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
Time frame: Start of the GPS to 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 21211643Nelson 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.
- 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 10 mg Rescue Treatment and Olopatadine 0.1% 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: Start of the GPS to 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 NCT00562159, 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.