Allergic RhinitisPhase 2Pollen+NCT02005627
Grass Pollen Allergen Immunotherapy Tablet (AIT) Time Course Study
A Phase 2 study testing Grazax in people with Allergic Rhinitis, run by Imperial College London at 1 site in United Kingdom.
Trial summary
About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the eyes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Grazax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2013to 1 Mar 2017
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 to 65
- grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May-July.
- moderate to severe rhinoconjunctivitis symptoms with or without mild seasonal asthma interfering with usual daily activities/sleep.
- rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
- Positive skin prick test response (wheal diameter ≥ 3 mm) to timothy grass pollen.
- Positive specific immunoglobulin E (IgE), defined as IgE immunoCAP ≥ 0.7 Immuno Solid Phase Allergenchip (ISAC) standardized units (ISU), against timothy grass pollen.
Show all 14Show fewer
- if applicable a negative urine pregnancy test and willingness to use an effective form of contraception for the duration of involvement in the study.
- The ability to give informed consent and comply with study procedures.
- A positive grass pollen nasal allergen challenge test as defined by a total nasal symptom score (TNSS) of at least 7/12 after 5 minutes with an allergen dose of 5,000 bioequivalent units (BU)/ml.
- age 18 to 65.
- Negative skin prick test response to timothy grass pollen and panel of aeroallergens.
- Negative specific IgE, defined as IgE immunoCAP < 0.35 ISU, against timothy grass pollen.
- If applicable a negative urine pregnancy test at the time of screening and willingness to use an effective form of contraception for the duration of involvement in the study.
- The ability to give informed consent and comply with study procedures.
Who cannot join
- Previous grass pollen allergen immunotherapy.
- Prebronchodilator forced expiratory volume at one second (FEV1) < 70% of predicted value out of grass-pollen season.
- A clinical history of symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly exposed.
- Perennial asthma requiring regular inhaled corticosteroids.
- Seasonal symptoms outside the grass-pollen season.
- History of emergency visit or hospital admission for asthma in the previous 12 months.
Show all 33Show fewer
- History of chronic obstructive pulmonary disease.
- History of significant recurrent acute sinusitis.
- History of chronic sinusitis.
- At screening visit evidence for upper respiratory tract infection.Participants may be re-evaluated for eligibility after symptoms resolve.
- Current smokers or a history of ≥ 5 pack years.
- History of life-threatening anaphylaxis or angioedema.
- Ongoing systemic immunosuppressive treatment.
- The use of any investigational drug within 30 days of the screening visit.
- The presence of any medical condition that the investigator deems incompatible with participation in the study.
- History of fish allergy with positive skin test and/or positive specific IgE test to vertebrate/finned fish.
- Contraindications taking Grazax.
- Non-Atopic:
- Previous grass pollen allergen immunotherapy.
- Prebronchodilator FEV1 < 70% of predicted value out of grass-pollen season.
- symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly and perennially exposed (e.g. cat dander).
- Perennial asthma requiring regular inhaled corticosteroids.
- Seasonal symptoms outside or during the grass-pollen season.
- History of emergency visit or hospital admission for asthma in the previous 12 months.
- History of chronic obstructive pulmonary disease.
- History of significant recurrent acute sinusitis.
- History of chronic sinusitis.
- At screening visit, current symptoms of upper respiratory tract infection. Participants may be re-evaluated for eligibility after symptoms resolve.
- Current smokers or a history of ≥ 5 pack years.
- History of life-threatening anaphylaxis or angioedema.
- Ongoing systemic immunosuppressive treatment.
- The use of any investigational drug within 30 days of the screening visit.
- The presence of any medical condition that the investigator deems incompatible with participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Placebo-controlled Study of Grass Pollen Allergen Immunotherapy Tablet (AIT) for Seasonal Rhinitis: Time Course of Nasal, Cutaneous and Immunological Outcomes
About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for approximately 7 times more doctors' appointments than asthma. The standard treatment for hay fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in a survey taken in a UK general practice less than 40% of patients with hay fever reported good symptom control with this standard treatment. For those patients with hay fever whose symptoms are not well controlled by treatment with antihistamines and nasal sprays, subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a period of 3-5 years) is an effective alternative, and is approved in the UK on a named patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed, including grass pollen allergen tablets. These have been shown to be highly effective in the treatment of hay fever, with the additional benefit of being convenient for patients, given that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of troublesome grass pollen induced hay fever. The aim of this research is to investigate the effects of the AIT treatment on the immune system over time - which changes are taking place and when in the course of treatment. This will provide insight into the complexities of the development of allergen-specific immune tolerance - how harmful allergic responses against innocuous substances such as grass pollen can be overridden.
Read the detailed description
The study will be conducted over 44 months. We expect to screen 70 atopic patients in order to enroll up to 50 suitable atopic participants to ensure randomisation of at least 40 atopic participants following their baseline visit. Additionally, we shall recruit 20 healthy, non-atopic volunteers. Individuals with moderate to severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited and screened after the pollen season from September through March 2014. Atopic Participants will undergo baseline assessments in December 2013 to March 2014. All screening assessments will be completed before eligible participants are randomized to active or placebo treatment. Atopic participants will then begin AIT treatment in February-March 2014 and continue treatment for 12 months. All atopic participants will be provided with anti-allergic rescue medications (antihistamine tablets, topical intranasal corticosteroids, and eye-drops) throughout the pollen season. Clinical surrogate endpoint assessments and on specific time Points blood, nasal fluid and nasal brushing sampling, will be performed at baseline (January-March 2014), at 4, 8, 12 and 16 weeks after starting the AIT, and at 6 and at 12 months (January-March 2015) of treatment. Nasal mucosal biopsies will be taken at baseline, during the Peak pollen season, and 12 months of treatment. After 12 months of treatment, unblinding will take place. Those atopic participants receiving active AIT treatment will continue therapy for another 12 months followed by a withdrawal phase of 12 months. Blood samples and nasal biopsies will be taken from these participants again at 24 and at 36 months from the initial start of treatment. Those atopic participants on placebo will be offered 24 months of active treatment after unblinding.
20 healthy, non-atopic participants will also be recruited and studied on a single day before and after nasal challenge at one timepoint at 12 months. They will undergo the same clinical and immunological measurements as for the 46 randomised subjects participating in the clinical trial. The healthy subjects will undergo no therapeutic intervention and serve as controls for the immunological measurements.
The study will receive monitoring by:
- the sponsor, Imperial College London and audits by:
- Medicines for human use (clinical trials) regulations authority (MHRA)
We will assess the clinical data on paper case report forms and will use Inform as a database in order to verify completeness of data entry.
The Inform database also includes normal ranges of parameters if relevant.
Standard Operating Procedures are in place regarding clinical measures (e.g. nasal allergen challenges, nasal biopsies etc.) as well as data management (e.g. the Trial Master File), reporting of adverse events and data collection. All involved investigators are informed about these procedures and have current Good Clinical Practice (GMC) instructions.
Statistical analysis will be with non-parametric statistics taking into account treatment effect baseline values and visit number. Inclusion of 20 participants per group will give greater than 90% power (p=0.05) to detect a 40% reduction in the early phase response (EPR) after nasal challenge (AUC of the TNSS in the first 60 minutes after challenge, a 40% reduction in the skin late phase response (LPR), and a 50% increase in grass pollen allergen specific immunoglobulin G4 (IgG4) for AIT vs. placebo.
Based on more recent nasal allergen challenge studies (Scadding et al, unpublished data; mean 4.63, standard deviation 1.65 for AUC 0-60 minutes post grass pollen nasal challenge in 14 allergic volunteers), inclusion of 13 patients per group will provide 80% power to detect a 40% reduction in AUC after challenge, whereas inclusion of 22 patients per group will provide 80% power to detect a 30% reduction.
Further based on a recent study (Scadding et al, unpublished data; mean 70.14, standard deviation 14.17 for cross-sectional area in cm2 at 8 hours for skin late phase response to intradermal grass pollen injection), inclusion of 7 participants per group will provide 80% power to detect a 30% reduction, whereas inclusion of 10 participants per group will provide 90% power to detect a 30% reduction.
Intent-to-treat (ITT) sample will be defined as all randomized participants. ITT participants will be analysed with the group to which they were randomized, regardless of the medication actually received. If participants drop out post randomisation, they will be invited to complete study assessments throughout the duration of the trial.
Per-protocol (PP) sample will be defined as ITT sample participants who remain in the study for 12 months and in whom the primary endpoints were assessed. Participants in the PP sample must be compliant with study medication, defined as taking 75% or more of their study medication for the duration of the study. Compliance with study medication will be as assessed by pill count for returned AIT/placebo. Participants in the PP sample will be analysed with the group to which they were randomized. The non-atopics will also be included in the PP sample.
Safety sample (SS) will be defined as all enrolled participants.
Analysis of study data will be conducted to address all objectives of the trial and other interrelationships among all data elements of interest to the investigators and of relevance to the objectives of the study. Primary analysis of treatment effect will be conducted under the intention-to-treat (ITT) principle of eligible patients, whereby outcome data from all eligible patients will be included regardless of treatment compliance. In addition to the analyses described in sections below, summary descriptive statistics will be provided in the following manner: continuous data will be summarized descriptively by mean, standard deviation, median, and range; categorical data will be presented as enumerations and percentages.
Analysis of primary endpoint:
The primary endpoint will be analysed using the ITT and the PP sample. The analysis of the primary endpoint will compare the mean EPR to nasal challenge recorded by the TNSS during the first 60 minutes after the nasal challenge, at 12 months of therapy. Comparison between active and placebo groups will be assessed using ANOVA at the 0.05 level of significance.
Analysis of secondary endpoint:
All secondary analyses will be treated as supportive. P-values will be presented for the secondary endpoints but will not be adjusted for multiplicity and should be interpreted with caution. Findings will be evaluated in the context of the available body of knowledge and with respect to other findings.
- Conditions
- Allergic Rhinitis
- Being tested
- Grazax, Grazax Placebo
- Keywords
- grass pollen allergy, hayfever, atopy, allergic rhinitis, sublingual immunotherapy tablets
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazaxDrug
Also called Grazax 75,000 SQ-T oral lyophilisate, Allergen Immunotherapy Tablet, SQ Standardized Grass Allergy Immunotherapy
The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.
Grazax PlaceboDrug
Also called Grazax Placebo tablet
This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
| Study group | Role | What they receive |
|---|---|---|
| Grazax | Active comparator | The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily. Receives: Drug: Grazax |
| Grazax Placebo | Placebo comparator | This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. Receives: Drug: Grazax Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score After Nasal Allergen Challenge (NAC)
The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.
Measured: 60 minutes post-challenge after 12 months of treatment
Secondary outcomes (4)
Early Phase Intradermal Test
Mean Diameter in millimetre of EPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms.
Measured: after 12 months of treatment
Late Phase Intradermal Test
Mean Diameter in millimetre of LPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms
Measured: after 12 months of treatment
Change From Baseline in Delta Peak Nasal Inspiratory Flow in L/Min
Nasal patency assessed at 60 minutes after nasal allergen challenge 12 months after treatment. The lower the peak nasal inspiratory flow the blockage nasal patency is.
Measured: 60 minutes post-challenge after 12 months of treatment
End of Season Global Rhinitis Symptoms
Hayfever symptoms during last pollen season after start of treatment. Score on a scale ranges from minimum 0 point to maximum of 100 points. Higher score is more severe symptoms.
Measured: after treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study start1 Sep 2013
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, ALK-Abelló A/S, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Stephen R Durham, Prof., Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005627
- Sponsor's protocol ID
- 13IC0847
- Other IDs
- 2013-003732-72, 13/EM/0351
- Acronym
- Pollen+
- Status last verified
- Nov 2019
- First submitted
- 4 Dec 2013
- Last updated
- 4 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steveling EH, Lao-Araya M, Koulias C, Scadding G, Eifan A, James LK, Dumitru A, Penagos M, Calderon M, Andersen PS, Shamji M, Durham SR. Protocol for a randomised, double-blind, placebo-controlled study of grass allergen immunotherapy tablet for seasonal allergic rhinitis: time course of nasal, cutaneous and immunological outcomes. Clin Transl Allergy. 2015 Dec 17;5:43. doi: 10.1186/s13601-015-0087-2. eCollection 2015.
PubMed 26682038
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Placebo-controlled Study of Grass Pollen Allergen Immunotherapy Tablet (AIT) for Seasonal Rhinitis: Time Course of Nasal, Cutaneous and Immunological Outcomes
- ClinicalTrials.gov ID
- NCT02005627
- Acronym / sponsor ID
- Pollen+ / 13IC0847
- Conditions
- Allergic Rhinitis
- Keywords
- grass pollen allergy, hayfever, atopy, allergic rhinitis, sublingual immunotherapy tablets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- King's College London, ALK-Abelló A/S, Wellcome Trust
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About 45 million people in Europe have allergic rhinitis (hay fever) - inflammation of the nasal passages causing sneezing, runny nose, nasal congestion, itching and tearing of the eyes. In the United Kingdom (UK), seasonal hay fever due to grass pollen allergy accounts for approximately 7 times more doctors' appointments than asthma. The standard treatment for hay fever consists of treating the symptoms with a nasal spray and an antihistamine. However, in a survey taken in a UK general practice less than 40% of patients with hay fever reported good symptom control with this standard treatment. For those patients with hay fever whose symptoms are not well controlled by treatment with antihistamines and nasal sprays, subcutaneous immunotherapy (SCIT) - (monthly injections of a grass allergen extract for a period of 3-5 years) is an effective alternative, and is approved in the UK on a named patient basis. More recently, allergen immunotherapy tablets (AITs) have been developed, including grass pollen allergen tablets. These have been shown to be highly effective in the treatment of hay fever, with the additional benefit of being convenient for patients, given that they may be taken at home. Grazax® (manufactured by Allergologisk Laboratorium København (ALK)-Abello, Denmark) has UK and European Union (EU) license for use in the treatment of troublesome grass pollen induced hay fever. The aim of this research is to investigate the effects of the AIT treatment on the immune system over time - which changes are taking place and when in the course of treatment. This will provide insight into the complexities of the development of allergen-specific immune tolerance - how harmful allergic responses against innocuous substances such as grass pollen can be overridden.
Detailed description
The study will be conducted over 44 months. We expect to screen 70 atopic patients in order to enroll up to 50 suitable atopic participants to ensure randomisation of at least 40 atopic participants following their baseline visit. Additionally, we shall recruit 20 healthy, non-atopic volunteers. Individuals with moderate to severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited and screened after the pollen season from September through March 2014. Atopic Participants will undergo baseline assessments in December 2013 to March 2014. All screening assessments will be completed before eligible participants are randomized to active or placebo treatment. Atopic participants will then begin AIT treatment in February-March 2014 and continue treatment for 12 months. All atopic participants will be provided with anti-allergic rescue medications (antihistamine tablets, topical intranasal corticosteroids, and eye-drops) throughout the pollen season. Clinical surrogate endpoint assessments and on specific time Points blood, nasal fluid and nasal brushing sampling, will be performed at baseline (January-March 2014), at 4, 8, 12 and 16 weeks after starting the AIT, and at 6 and at 12 months (January-March 2015) of treatment. Nasal mucosal biopsies will be taken at baseline, during the Peak pollen season, and 12 months of treatment. After 12 months of treatment, unblinding will take place. Those atopic participants receiving active AIT treatment will continue therapy for another 12 months followed by a withdrawal phase of 12 months. Blood samples and nasal biopsies will be taken from these participants again at 24 and at 36 months from the initial start of treatment. Those atopic participants on placebo will be offered 24 months of active treatment after unblinding.
20 healthy, non-atopic participants will also be recruited and studied on a single day before and after nasal challenge at one timepoint at 12 months. They will undergo the same clinical and immunological measurements as for the 46 randomised subjects participating in the clinical trial. The healthy subjects will undergo no therapeutic intervention and serve as controls for the immunological measurements.
The study will receive monitoring by:
- the sponsor, Imperial College London and audits by:
- Medicines for human use (clinical trials) regulations authority (MHRA)
We will assess the clinical data on paper case report forms and will use Inform as a database in order to verify completeness of data entry.
The Inform database also includes normal ranges of parameters if relevant.
Standard Operating Procedures are in place regarding clinical measures (e.g. nasal allergen challenges, nasal biopsies etc.) as well as data management (e.g. the Trial Master File), reporting of adverse events and data collection. All involved investigators are informed about these procedures and have current Good Clinical Practice (GMC) instructions.
Statistical analysis will be with non-parametric statistics taking into account treatment effect baseline values and visit number. Inclusion of 20 participants per group will give greater than 90% power (p=0.05) to detect a 40% reduction in the early phase response (EPR) after nasal challenge (AUC of the TNSS in the first 60 minutes after challenge, a 40% reduction in the skin late phase response (LPR), and a 50% increase in grass pollen allergen specific immunoglobulin G4 (IgG4) for AIT vs. placebo.
Based on more recent nasal allergen challenge studies (Scadding et al, unpublished data; mean 4.63, standard deviation 1.65 for AUC 0-60 minutes post grass pollen nasal challenge in 14 allergic volunteers), inclusion of 13 patients per group will provide 80% power to detect a 40% reduction in AUC after challenge, whereas inclusion of 22 patients per group will provide 80% power to detect a 30% reduction.
Further based on a recent study (Scadding et al, unpublished data; mean 70.14, standard deviation 14.17 for cross-sectional area in cm2 at 8 hours for skin late phase response to intradermal grass pollen injection), inclusion of 7 participants per group will provide 80% power to detect a 30% reduction, whereas inclusion of 10 participants per group will provide 90% power to detect a 30% reduction.
Intent-to-treat (ITT) sample will be defined as all randomized participants. ITT participants will be analysed with the group to which they were randomized, regardless of the medication actually received. If participants drop out post randomisation, they will be invited to complete study assessments throughout the duration of the trial.
Per-protocol (PP) sample will be defined as ITT sample participants who remain in the study for 12 months and in whom the primary endpoints were assessed. Participants in the PP sample must be compliant with study medication, defined as taking 75% or more of their study medication for the duration of the study. Compliance with study medication will be as assessed by pill count for returned AIT/placebo. Participants in the PP sample will be analysed with the group to which they were randomized. The non-atopics will also be included in the PP sample.
Safety sample (SS) will be defined as all enrolled participants.
Analysis of study data will be conducted to address all objectives of the trial and other interrelationships among all data elements of interest to the investigators and of relevance to the objectives of the study. Primary analysis of treatment effect will be conducted under the intention-to-treat (ITT) principle of eligible patients, whereby outcome data from all eligible patients will be included regardless of treatment compliance. In addition to the analyses described in sections below, summary descriptive statistics will be provided in the following manner: continuous data will be summarized descriptively by mean, standard deviation, median, and range; categorical data will be presented as enumerations and percentages.
Analysis of primary endpoint:
The primary endpoint will be analysed using the ITT and the PP sample. The analysis of the primary endpoint will compare the mean EPR to nasal challenge recorded by the TNSS during the first 60 minutes after the nasal challenge, at 12 months of therapy. Comparison between active and placebo groups will be assessed using ANOVA at the 0.05 level of significance.
Analysis of secondary endpoint:
All secondary analyses will be treated as supportive. P-values will be presented for the secondary endpoints but will not be adjusted for multiplicity and should be interpreted with caution. Findings will be evaluated in the context of the available body of knowledge and with respect to other findings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazax | Active comparator | Drug: GrazaxThe active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 standardised quality units tablet (SQ-T) once daily. |
| Grazax Placebo | Placebo comparator | Drug: Grazax PlaceboThis arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- age 18 to 65
- grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May-July.
- moderate to severe rhinoconjunctivitis symptoms with or without mild seasonal asthma interfering with usual daily activities/sleep.
- rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
- Positive skin prick test response (wheal diameter ≥ 3 mm) to timothy grass pollen.
Key exclusion criteria (33 listed)
- Previous grass pollen allergen immunotherapy.
- Prebronchodilator forced expiratory volume at one second (FEV1) < 70% of predicted value out of grass-pollen season.
- A clinical history of symptomatic allergic rhinitis and/or asthma caused by an allergen to which the participant is regularly exposed.
- Perennial asthma requiring regular inhaled corticosteroids.
- Seasonal symptoms outside the grass-pollen season.
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 |
|---|---|---|
| GrazaxAlso: Grazax 75,000 SQ-T oral lyophilisate, Allergen Immunotherapy Tablet, SQ Standardized Grass Allergy ImmunotherapyThe active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily. | Drug | Grazax |
| Grazax PlaceboAlso: Grazax Placebo tabletThis arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract. | Drug | Grazax Placebo |
Primary outcome
Total Nasal Symptom Score After Nasal Allergen Challenge (NAC)
Time frame: 60 minutes post-challenge after 12 months of treatment
The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.
4 secondary outcomes
Early Phase Intradermal Test
Time frame: after 12 months of treatment
Late Phase Intradermal Test
Time frame: after 12 months of treatment
Change From Baseline in Delta Peak Nasal Inspiratory Flow in L/Min
Time frame: 60 minutes post-challenge after 12 months of treatment
End of Season Global Rhinitis Symptoms
Time frame: after treatment at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26682038Steveling EH, Lao-Araya M, Koulias C, Scadding G, Eifan A, James LK, Dumitru A, Penagos M, Calderon M, Andersen PS, Shamji M, Durham SR. Protocol for a randomised, double-blind, placebo-controlled study of grass allergen immunotherapy tablet for seasonal allergic rhinitis: time course of nasal, cutaneous and immunological outcomes. Clin Transl Allergy. 2015 Dec 17;5:43. doi: 10.1186/s13601-015-0087-2. eCollection 2015.
- Individual participant dataSharing planned: No
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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 R Durham, Prof. principal investigator
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 Grazax in people with Allergic Rhinitis, run by Imperial College London 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 14 inclusion and 33 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 4 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2019). 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?
Total Nasal Symptom Score After Nasal Allergen Challenge (NAC) (time frame: 60 minutes post-challenge after 12 months of treatment). 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 NCT02005627, which also lists 1 linked publication.
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 4 Dec 2019.