Rhinitis, Allergic, SeasonalPhase 3NCT00135629
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
A Phase 3 study testing Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ). and Venepuncture: 100ml blood sample taken on 12 separate visits in people with Rhinitis, Allergic, Seasonal, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. 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?
- Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ). and Venepuncture: 100ml blood sample taken on 12 separate visits
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2002to Oct 2008
- Phase
- Phase 3
- 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
- Male and female 18-65 years of age
- Written informed consent obtained before entering the trial
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season
- Positive Skin Prick Test (SPT) response (wheal diameter ≥ 3 mm) to Phleum pratense
- Positive specific IgE against Phleum pratense (≥ IgE Class 2)
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- Physical examination with no clinically relevant findings
- If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the trial
- Willingness to comply with this protocol
Who cannot join
- FEV1 < 70% of predicted value
- A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of - and potentially overlapping - the grass pollen season
- A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
- A clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
- At randomisation, 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)
- History of emergency visit or admission for asthma in the previous 12 months
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- Use of an investigational drug within 30 days prior to screening
- Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
- History of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
- History of angioedema
- Any of the following underlying conditions known or suspected to be present:
- Cystic fibrosis
- Malignancy
- Insulin-dependent diabetes
- Malabsorption or malnutrition
- Renal or hepatic insufficiency
- Chronic infection
- Drug dependency or alcoholism
- Ischemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease)
- Immunosuppressive treatment
- History of hypersensitivity to the excipients of the trial medications
- History of allergy, hypersensitivity or intolerance to trial medications or rescue medications
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude
- Unlikely to be able to complete the trial, for any reason, or likely to travel for extended periods of time during the grass pollen season
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton Hospital, NHLI Imperial College
London, SW3 6LY
About this study
Official title: Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever: A Pilot Study. (Up-dosing Study)
The purpose of this study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.
Read the detailed description
This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ)., Placebo Injection, Venepuncture: 100ml blood sample taken on 12 separate visits
- Keywords
- Hayfever, Sublingual Immunotherapy, Grass pollen immunotherapy, Late cutaneous response, Intradermal allergen challenge, Seasonal Allergic Rhinoconjunctivitis
- 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.
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).Biological
Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).
Placebo InjectionOther
Placebo Injection
Venepuncture: 100ml blood sample taken on 12 separate visitsProcedure or surgery
Venepuncture: 100ml blood sample taken on 12 separate visits
| Study group | Role | What they receive |
|---|---|---|
| Immunotherpy Arm | Experimental | 12 patients received active injections of an alum-adsorbed grass pollen vaccine Receives: Biological: Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).; Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits |
| Placebo Arm | Placebo comparator | 6 patients received placebo injections Receives: Other: Placebo Injection; Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and medication score recorded by subjects
Overall assessment of symptoms was recorded on a numeric scale (-3 to +3) by each patient at the end of the study
Measured: Assessment scores obtained after 12 months of treatment
Adverse events (conjunctival symptoms)
Conjunctival symptoms elicitation with P-pratense allergen (reduced response detection)
Measured: 10 minutes post-conjunctival allergen provocation after 12 months of treatment
Secondary outcomes (1)
Intradermal allergen challenge
All patients underwent re-peated venesection and intradermal allergen challenge for testing of early and late skin responses: allergen-induced cytokine production over 10 months (reduced response change to P pratense-specific antigens). Intradermal allergen challenge for testing of early and late skin responses at biweekly intervals during updosing and at monthly intervals during the maintenance phase.
Measured: Biweekly during up-dosing and then monthly upto 6 months, and up to 12 months following initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startOct 2002
- Primary completionJan 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm, randomized, double-blind trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- ALK-Abelló A/S
- Responsible party
- Sponsor
- Investigators
- Stephen R Durham, Professor, Principal investigator, Royal Brompton Hospital, Imperial College, National Heart & Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135629
- Sponsor's protocol ID
- DHRG-UpDosing
- Status last verified
- May 2024
- First submitted
- 25 Aug 2005
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francis JN, James LK, Paraskevopoulos G, Wong C, Calderon MA, Durham SR, Till SJ. Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity. J Allergy Clin Immunol. 2008 May;121(5):1120-1125.e2. doi: 10.1016/j.jaci.2008.01.072. Epub 2008 Apr 18.
PubMed 18374405
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever: A Pilot Study. (Up-dosing Study)
- ClinicalTrials.gov ID
- NCT00135629
- Acronym / sponsor ID
- DHRG-UpDosing
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Hayfever, Sublingual Immunotherapy, Grass pollen immunotherapy, Late cutaneous response, Intradermal allergen challenge, Seasonal Allergic Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- ALK-Abelló A/S
- Study start
- Oct 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Aug 2005 (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 study is to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Symptom scores and need of rescue medication were recorded by patients during the study period. The size of early and late cutaneous response to allergen challenge was recorded and measured by a physician.
Detailed description
This was a single centre, randomised, double-blind placebo controlled trial of grass pollen injection immunotherapy (Alutard SQ, ALK Abello, Denmark) in adults with severe summer hayfever unresponsive to antihistamines and topical steroids. The main aim was to determine at which point in the dosing regime grass pollen immunotherapy causes a significant reduction in the late skin response to allergen challenge. A once weekly cluster regimen of 2 injections per visit was employed during the up-dosing phase, followed by monthly maintenance injections of 100,000 SQ units. Twelve patients received active treatment (mean age 31, 7 male) whilst 6 were given placebo (mean age 37, 2 male). The 24 hour skin response (size of swelling, (mm)) to intradermal allergen challenge (0.1, 1, 10 BU) was determined on alternate weeks during the 8 week up-dosing phase and then monthly up to 6 months and 3 monthly up to 11-13 months following initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 arm, randomized, double-blind trial
| Arm | Type | Receives |
|---|---|---|
| Immunotherpy Arm | Experimental | Biological: Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ)., Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits12 patients received active injections of an alum-adsorbed grass pollen vaccine |
| Placebo Arm | Placebo comparator | Other: Placebo Injection, Procedure: Venepuncture: 100ml blood sample taken on 12 separate visits6 patients received placebo injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female 18-65 years of age
- Written informed consent obtained before entering the trial
- A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season
- A clinical history of severe rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep), which remain troublesome despite treatment with anti-allergic drugs during the grass pollen season
- Positive Skin Prick Test (SPT) response (wheal diameter ≥ 3 mm) to Phleum pratense
Key exclusion criteria (24 listed)
- FEV1 < 70% of predicted value
- A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of - and potentially overlapping - the grass pollen season
- A clinical history of significant symptomatic perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed
- A clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
- At randomisation, 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)
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 |
|---|---|---|
| Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ).Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ). | Biological | Immunotherpy Arm |
| Placebo InjectionPlacebo Injection | Other | Placebo Arm |
| Venepuncture: 100ml blood sample taken on 12 separate visitsVenepuncture: 100ml blood sample taken on 12 separate visits | Procedure or surgery | Immunotherpy Arm, Placebo Arm |
Primary outcome
Symptom and medication score recorded by subjects
Time frame: Assessment scores obtained after 12 months of treatment
Overall assessment of symptoms was recorded on a numeric scale (-3 to +3) by each patient at the end of the study
Adverse events (conjunctival symptoms)
Time frame: 10 minutes post-conjunctival allergen provocation after 12 months of treatment
Conjunctival symptoms elicitation with P-pratense allergen (reduced response detection)
1 secondary outcome
Intradermal allergen challenge
Time frame: Biweekly during up-dosing and then monthly upto 6 months, and up to 12 months following initiation of treatment.
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 16 May 2024.
- Results publication: PubMed 18374405Francis JN, James LK, Paraskevopoulos G, Wong C, Calderon MA, Durham SR, Till SJ. Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity. J Allergy Clin Immunol. 2008 May;121(5):1120-1125.e2. doi: 10.1016/j.jaci.2008.01.072. Epub 2008 Apr 18.
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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, Professor principal investigator
Royal Brompton Hospital, Imperial College, National Heart & Lung Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active injections of alum-adsorbed grass pollen vaccine (Alutard SQ). and Venepuncture: 100ml blood sample taken on 12 separate visits in people with Rhinitis, Allergic, Seasonal, 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 9 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 16 May 2024. 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 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?
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?
Symptom and medication score recorded by subjects (time frame: Assessment scores obtained after 12 months of treatment). The study lists 2 primary outcomes in all. 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 NCT00135629, 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 16 May 2024.