Rhinitis, Allergic, SeasonalPhase 2NCT01335139
Long-Term Effects of Sublingual Grass Therapy
A Phase 2 study testing Sublingual immunotherapy (SLIT) and Subcutaneous immunotherapy (SCIT) in people with Rhinitis, Allergic, Seasonal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Sublingual immunotherapy (SLIT) and Subcutaneous immunotherapy (SCIT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July;
- A clinical history of moderate to severe rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep as defined according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis;
- A clinical history of rhinoconjunctivitis for at least 2 years requiring treatment with either antihistamines or nasal corticosteroids during the grass pollen season;
- Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense (e.g., Timothy grass);
- Positive specific IgE, defined as greater than or equal to IgE class 2 (0.7 kU/L), against Phleum pratense;
- A positive response to nasal allergen challenge with Phleum pretense, defined as an increase in TNSS greater than or equal to 7 points above baseline;
- For women of childbearing age, a willingness to use an effective form of contraception for the duration of the trial; and
- The ability to give informed consent and comply with study procedures.
Who cannot join
- Prebronchodilator forced expiratory volume at 1 second (FEV1) less than 70% of predicted value at either screening or baseline visit;
- A clinical history of moderate to severe allergic rhinitis, according to the ARIA classification, due to tree pollen near or overlapping the grass pollen season;
- A clinical history of persistent asthma and/or requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season;
- A clinical history of moderate- severe allergic rhinitis, according to the ARIA classification, caused by an allergen to which the participant is regularly exposed;
- History of emergency visit or hospital admission for asthma in the previous 12 months;
- History of chronic obstructive pulmonary disease;
Show all 19Show fewer
- History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment;
- History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
- At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
- Any tobacco smoking within the last 6 months or a history of ≥ 10 pack years;
- Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years.
- Any history of grade 4 anaphylaxis due to any cause as defined by the World Allergy Organization (WAO) grading criteria for immunotherapy;
- History of bleeding disorders or treatment with anticoagulation therapy;
- History of anti-IgE monoclonal antibody treatment;
- Ongoing systemic immunosuppressive treatment;
- History of intolerance to the study therapy, rescue medications, or their excipients;
- For women of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours before the start of study therapy;
- The use of any investigational drug within 30 days of the screening visit; or
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)
The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.
Read the detailed description
This is a randomized, double-blind, single-center, placebo-controlled, three-arm study comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT and placebo.
Individuals with severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited during the pollen season of March through September 2011. Eligible participants will be randomized to one of the following three treatment arms administered in a double-blind (masked), double-dummy fashion in a 1:1:1 ratio:
- SLIT + SCIT placebo
- SCIT + SLIT placebo
- SLIT placebo + SCIT placebo
Participants will receive treatment over a 2-year period followed by a 1-year blinded (masked) withdrawal phase. Participants will be provided with anti-allergic rescue medications (antihistamine, topical intranasal corticosteroids, and short-acting beta agonists) throughout the study. Clinical endpoint assessments will be performed at prior to initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year withdrawal period at 3 years.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Sublingual immunotherapy (SLIT), Subcutaneous immunotherapy (SCIT), Placebo
- Keywords
- sublingual immunotherapy, subcutaneous immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual immunotherapy (SLIT)Biological
Also called Grazax®
Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections.
Subcutaneous immunotherapy (SCIT)Biological
Also called Alutard SQ Grass Pollen®
Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control.
PlaceboOther
Participants randomized to double-placebo tablets and injections. This group was included as a negative control.
| Study group | Role | What they receive |
|---|---|---|
| SCIT + Placebo | Experimental | Subcutaneous immunotherapy (SCIT) + sublingual immunotherapy (SLIT) placebo Receives: Biological: Subcutaneous immunotherapy (SCIT); Other: Placebo |
| SLIT + Placebo | Experimental | Sublingual immunotherapy (SLIT) + subcutaneous immunotherapy (SCIT) placebo Receives: Biological: Sublingual immunotherapy (SLIT); Other: Placebo |
| Placebo + Placebo | Placebo comparator | Sublingual immunotherapy (SLIT) placebo + subcutaneous immunotherapy (SCIT) placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Response to Allergen Challenge
Defined as the average of the Total Nasal Symptom Score (TNSS) area under the curve (AUC) measured at 0 to 1 hours and the AUC measured at 1 to 10 hours after allergen challenge. The primary outcome consists of the comparison of SLIT + SCIT placebo versus SLIT placebo + SCIT placebo.
Measured: 3 years
Secondary outcomes (15)
Skin Late Phase Response (LPR) to Intradermal Testing
Recorded as the mean diameter of the swelling measured at the specified time points after allergen challenge at 1, 2, and 3 years. The analysis of this outcome will compare the mean diameter of the swelling at 1, 2, and 3 years separately, adjusting for baseline diameter using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1,-2, and -3 years
Skin Early Phase Response (EPR) to Intradermal Testing
Recorded as the mean diameter of the swelling measured at the specified time points after allergen challenge at 1, 2, and 3 years. The analysis of this outcome will compare the mean diameter of the swelling at 1, 2, and 3 years separately, adjusting for baseline diameter using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Nasal LPR
Defined as the TNSS AUC over the specified time periods after allergen challenge at 1, 2, and 3 years. The analysis of these this outcome will compare the mean TNSS AUC at 1, 2, and 3 years separately, adjusting for baseline LPR using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Nasal EPR
Defined as the TNSS AUC over the specified time periods after allergen challenge at 1, 2, and 3 years. The analysis of these this outcome will compare the mean TNSS AUC at 1, 2, and 3 years separately, adjusting for baseline EPR using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Peak Total Nasal Symptom Score (TNSS) EPR
Maximum TNSS score measured between 0 and 1 hour after challenge.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) LPR
Defined as PNIF AUC over the specified time periods after allergen challenge at 1, 2 and 3 years. The analyses for this outcome will compare the mean PNIF AUC at 1, 2, and 3 years separately, adjusting for baseline PNIF using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) LPR Area Under the Curve (AUC)
Defined as PNIF AUC over the specified time periods after allergen challenge at 1, 2 and 3 years. The analyses for this outcome will compare the mean PNIF AUC at 1, 2, and 3 years separately, adjusting for baseline PNIF using ANCOVA at the 0.05 level of significance.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) EPR Area Under the Curve (AUC)
Defined as PNIF AUC over the specified time periods after allergen challenge at 1, 2 and 3 years. The analyses for this outcome will compare the mean PNIF AUC at 1, 2, and 3 years separately, adjusting for baseline PNIF using ANCOVA at the 0.05 level of significance. AUC measured hourly between 1 and 10 hours after challenge.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Skin Prick Test Endpoint Titration
Assessed as the mean wheal diameters (mm) in response to skin prick tests in duplicate with 1000 SQ, 10,000 SQ and 100,000 SQ units of grass pollen allergen.
Measured: Baseline (Time 0) and 1, -2, and -3 years
Use of Rescue Medications During the Pollen Season
A composite rescue medication score will be derived using a pre-defined scoring algorithm.
Measured: 1, -2, and -3 years
Mini Rhinoconjunctivitis Quality-of-Life Questionnaire Score
Mini Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ) scores will be collected pre-, peak-, and post-pollen season at 1, 2, and 3 years.
Measured: 1, -2, and -3 years
Hay Fever Severity Score
Measured at the end of each pollen season at 1, -2, and -3 years.
Measured: 1, 2 and 3 years
Weekly Visual Analog Symptom (VAS) Scores
Weekly Visual Analogue Scale scores will be summarized descriptively by group and year.
Measured: 1, -2, and -3 years
EXPLORATORY: Mechanistic Assessments of Local Immune Responses
Measured in the nasal mucosa before and after nasal allergen challenge. Nasal secretions will be assayed for inflammatory mediators and local antibodies.
Measured: 1, 2, and 3 years
EXPLORATORY: Mechanistic Assessments of Peripheral Blood Subsets
Peripheral blood mononuclear cells (PBMCs) samples will be analyzed.
Measured: 1, 2, and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Imperial College London
- Responsible party
- Sponsor
- Investigators
- Stephen Durham, MD, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335139
- Sponsor's protocol ID
- DAIT ITN043AD
- Other IDs
- 2010-023536-16
- Status last verified
- May 2017
- First submitted
- 8 Apr 2011
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal. ITN TrialShare makes data from the consortium's clinical trials publicly available.
Publications
Cox LS. Sublingual Immunotherapy for Allergic Rhinitis: Is 2-Year Treatment Sufficient for Long-term Benefit? JAMA. 2017 Feb 14;317(6):591-593. doi: 10.1001/jama.2017.0128. No abstract available.
PubMed 28196239Scadding GW, Calderon MA, Shamji MH, Eifan AO, Penagos M, Dumitru F, Sever ML, Bahnson HT, Lawson K, Harris KM, Plough AG, Panza JL, Qin T, Lim N, Tchao NK, Togias A, Durham SR; Immune Tolerance Network GRASS Study Team. Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):615-625. doi: 10.1001/jama.2016.21040.
PubMed 28196255Altman MC, Segnitz RM, Larson D, Jayavelu ND, Smith MT, Patel S, Scadding GW, Qin T, Sanda S, Steveling E, Eifan AO, Penagos M, Jacobson MR, Parkin RV, Shamji MH, Togias A, Durham SR. Nasal and blood transcriptomic pathways underpinning the clinical response to grass pollen immunotherapy. J Allergy Clin Immunol. 2023 Nov;152(5):1247-1260. doi: 10.1016/j.jaci.2023.06.025. Epub 2023 Jul 15.
PubMed 37460024
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)
- ClinicalTrials.gov ID
- NCT01335139
- Acronym / sponsor ID
- DAIT ITN043AD
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- sublingual immunotherapy, subcutaneous immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Imperial College London
- Study start
- Mar 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
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 this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.
Detailed description
This is a randomized, double-blind, single-center, placebo-controlled, three-arm study comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT and placebo.
Individuals with severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited during the pollen season of March through September 2011. Eligible participants will be randomized to one of the following three treatment arms administered in a double-blind (masked), double-dummy fashion in a 1:1:1 ratio:
- SLIT + SCIT placebo
- SCIT + SLIT placebo
- SLIT placebo + SCIT placebo
Participants will receive treatment over a 2-year period followed by a 1-year blinded (masked) withdrawal phase. Participants will be provided with anti-allergic rescue medications (antihistamine, topical intranasal corticosteroids, and short-acting beta agonists) throughout the study. Clinical endpoint assessments will be performed at prior to initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year withdrawal period at 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCIT + Placebo | Experimental | Biological: Subcutaneous immunotherapy (SCIT), Other: PlaceboSubcutaneous immunotherapy (SCIT) + sublingual immunotherapy (SLIT) placebo |
| SLIT + Placebo | Experimental | Biological: Sublingual immunotherapy (SLIT), Other: PlaceboSublingual immunotherapy (SLIT) + subcutaneous immunotherapy (SCIT) placebo |
| Placebo + Placebo | Placebo comparator | Other: PlaceboSublingual immunotherapy (SLIT) placebo + subcutaneous immunotherapy (SCIT) placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July;
- A clinical history of moderate to severe rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep as defined according to the Allergic Rhinitis and its Impact on Asthma (ARIA) classification of rhinitis;
- A clinical history of rhinoconjunctivitis for at least 2 years requiring treatment with either antihistamines or nasal corticosteroids during the grass pollen season;
- Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense (e.g., Timothy grass);
- Positive specific IgE, defined as greater than or equal to IgE class 2 (0.7 kU/L), against Phleum pratense;
Key exclusion criteria (19 listed)
- Prebronchodilator forced expiratory volume at 1 second (FEV1) less than 70% of predicted value at either screening or baseline visit;
- A clinical history of moderate to severe allergic rhinitis, according to the ARIA classification, due to tree pollen near or overlapping the grass pollen season;
- A clinical history of persistent asthma and/or requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season;
- A clinical history of moderate- severe allergic rhinitis, according to the ARIA classification, caused by an allergen to which the participant is regularly exposed;
- History of emergency visit or hospital admission for asthma in the previous 12 months;
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 |
|---|---|---|
| Sublingual immunotherapy (SLIT)Also: Grazax®Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections. | Biological | SLIT + Placebo |
| Subcutaneous immunotherapy (SCIT)Also: Alutard SQ Grass Pollen®Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control. | Biological | SCIT + Placebo |
| PlaceboParticipants randomized to double-placebo tablets and injections. This group was included as a negative control. | Other | Placebo + Placebo, SCIT + Placebo, SLIT + Placebo |
Primary outcome
Nasal Response to Allergen Challenge
Time frame: 3 years
Defined as the average of the Total Nasal Symptom Score (TNSS) area under the curve (AUC) measured at 0 to 1 hours and the AUC measured at 1 to 10 hours after allergen challenge. The primary outcome consists of the comparison of SLIT + SCIT placebo versus SLIT placebo + SCIT placebo.
15 secondary outcomes
Skin Late Phase Response (LPR) to Intradermal Testing
Time frame: Baseline (Time 0) and 1,-2, and -3 years
Skin Early Phase Response (EPR) to Intradermal Testing
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Nasal LPR
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Nasal EPR
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Peak Total Nasal Symptom Score (TNSS) EPR
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) LPR
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) LPR Area Under the Curve (AUC)
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Peak Nasal Inspiratory Flow (PNIF) EPR Area Under the Curve (AUC)
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Skin Prick Test Endpoint Titration
Time frame: Baseline (Time 0) and 1, -2, and -3 years
Use of Rescue Medications During the Pollen Season
Time frame: 1, -2, and -3 years
Mini Rhinoconjunctivitis Quality-of-Life Questionnaire Score
Time frame: 1, -2, and -3 years
Hay Fever Severity Score
Time frame: 1, 2 and 3 years
Weekly Visual Analog Symptom (VAS) Scores
Time frame: 1, -2, and -3 years
EXPLORATORY: Mechanistic Assessments of Local Immune Responses
Time frame: 1, 2, and 3 years
EXPLORATORY: Mechanistic Assessments of Peripheral Blood Subsets
Time frame: 1, 2, and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Background: PubMed 28196239Cox LS. Sublingual Immunotherapy for Allergic Rhinitis: Is 2-Year Treatment Sufficient for Long-term Benefit? JAMA. 2017 Feb 14;317(6):591-593. doi: 10.1001/jama.2017.0128. No abstract available.
- Results publication: PubMed 28196255Scadding GW, Calderon MA, Shamji MH, Eifan AO, Penagos M, Dumitru F, Sever ML, Bahnson HT, Lawson K, Harris KM, Plough AG, Panza JL, Qin T, Lim N, Tchao NK, Togias A, Durham SR; Immune Tolerance Network GRASS Study Team. Effect of 2 Years of Treatment With Sublingual Grass Pollen Immunotherapy on Nasal Response to Allergen Challenge at 3 Years Among Patients With Moderate to Severe Seasonal Allergic Rhinitis: The GRASS Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):615-625. doi: 10.1001/jama.2016.21040.
- Derived from this study: PubMed 37460024Altman MC, Segnitz RM, Larson D, Jayavelu ND, Smith MT, Patel S, Scadding GW, Qin T, Sanda S, Steveling E, Eifan AO, Penagos M, Jacobson MR, Parkin RV, Shamji MH, Togias A, Durham SR. Nasal and blood transcriptomic pathways underpinning the clinical response to grass pollen immunotherapy. J Allergy Clin Immunol. 2023 Nov;152(5):1247-1260. doi: 10.1016/j.jaci.2023.06.025. Epub 2023 Jul 15.
- National Institute of Allergy and Infectious Disease (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- Immune Tolerance Network (ITN) TrialShare: open public access to participant-level data available for this trialLink provided by the sponsor.
- University of California, San Francisco (UCSF)Link provided by the sponsor.
- Imperial College LondonLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal. ITN TrialShare makes data from the consortium's clinical trials publicly available.
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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.
Stephen Durham, MD study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublingual immunotherapy (SLIT) and Subcutaneous immunotherapy (SCIT) in people with Rhinitis, Allergic, Seasonal, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United Kingdom.
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 8 inclusion and 19 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 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nasal Response to Allergen Challenge (time frame: 3 years). 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 NCT01335139, which also lists 3 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 2 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.