Rhinitis, Allergic, SeasonalPhase 3NCT00135642
Grass Pollen Immunotherapy Using a Cluster Regime for Seasonal Rhinitis and Asthma
A Phase 3 study testing Subcutaneous Alutard SQ grass pollen (Phleum pratense) and Venepuncture: 20 ml blood sample taken on 2 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 was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma. Hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness were… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- Subcutaneous Alutard SQ grass pollen (Phleum pratense) and Venepuncture: 20 ml blood sample taken on 2 separate visits
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 1996to Oct 1998
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female 18-60 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 ≥ 5 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
- Patients with seasonal asthma only if their baseline methacholine PC20 was greater than 2 mg/mL (normal range > 16 mg/ mL)
- 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: Randomized Double Blind Placebo Controlled Trial of Grass Pollen Immunotherapy Using a Cluster Regime
The purpose of this study was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma. Hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness were recorded during the study period.
Read the detailed description
This was a single centre, randomized, double-blind, placebo-controlled, parallel group study. The main aim of this study was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness, and quality of life in seasonal rhinitis and asthma. Forty-four patients with severe summer hay fever (of whom 36 reported seasonal chest symptoms and 28 had seasonal bronchial hyperresponsiveness) participated in a randomised double-blind, placebo-controlled, parallel group study. After symptom monitoring for one summer, participants matched placebo injections (n=22) in a rapid up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. Outcome measures included hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness.
Results: Significant reductions were observed in immunotherapy group compared with the placebo group in hay fever symptoms (49%, 15%: P = 0.1), medication scores (80%, 18%; P=.007), and seasonal chest symptoms (90%, 11%; P < .05). Impairment of overall quality of life (mean score of 7 domains) during the pollen season was less in the immunotherapy group than in the placebo group (median difference [95% CI], 0.8 [0.18-1.5]; P=.05=2]. During the pollen season, there was no change in airway methacholine PC20 (provocation concentration producing a 20% fall in FEV1) in the immunotherapy-treated group (P=5), compared with an almost 3 doubling-dose decrease in the placebo-treated group (P=.5), compared with an almost 3 doubling dose decrease in the placebo-treated group (P=.01, between-group difference). There were no significant local or systemic side effects during the study.
Conclusion: Grass pollen immunotherapy improves quality of life in seasonal allergic rhinitis and reduces seasonal asthma symptoms and bronchial hyperresponsiveness.
Note: Ongoing mechanistic studies and nasal biopsies studies until 2008
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- Subcutaneous Alutard SQ grass pollen (Phleum pratense), Venepuncture: 20 ml blood sample taken on 2 separate visits
- Keywords
- Hayfever, Subcutaneous Immunotherapy, Grass pollen immunotherapy, 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.
Subcutaneous Alutard SQ grass pollen (Phleum pratense)Biological
Venepuncture: 20 ml blood sample taken on 2 separate visitsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom and medication score recorded by subjects
Adverse events
Secondary outcomes (3)
Rhinoconjunctivitis Quality of Life Questionnaire
Seasonal bronchial hyperresponsiveness
Intradermal allergen challenge
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 startFeb 1996
- Study completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- ALK-Abelló A/S
- Investigators
- Stephen R Durham, Professor, Principal investigator, Royal Brompton Hospital, NHLI Imperial College London United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135642
- Sponsor's protocol ID
- DHRG-CLUSTER
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2005
- Last updated
- 14 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Trial of Grass Pollen Immunotherapy Using a Cluster Regime
- ClinicalTrials.gov ID
- NCT00135642
- Acronym / sponsor ID
- DHRG-CLUSTER
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Hayfever, Subcutaneous Immunotherapy, Grass pollen immunotherapy, Seasonal Allergic Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- ALK-Abelló A/S
- Study start
- Feb 1996
- Study completion
- Oct 1998
- 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 was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness and quality of life in seasonal rhinitis and asthma. Hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness were recorded during the study period.
Detailed description
This was a single centre, randomized, double-blind, placebo-controlled, parallel group study. The main aim of this study was to assess the effects of grass pollen immunotherapy on symptoms, bronchial hyperresponsiveness, and quality of life in seasonal rhinitis and asthma. Forty-four patients with severe summer hay fever (of whom 36 reported seasonal chest symptoms and 28 had seasonal bronchial hyperresponsiveness) participated in a randomised double-blind, placebo-controlled, parallel group study. After symptom monitoring for one summer, participants matched placebo injections (n=22) in a rapid up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. Outcome measures included hay fever symptoms and medication use, health-related quality of life, and measurements of non-specific bronchial responsiveness.
Results: Significant reductions were observed in immunotherapy group compared with the placebo group in hay fever symptoms (49%, 15%: P = 0.1), medication scores (80%, 18%; P=.007), and seasonal chest symptoms (90%, 11%; P < .05). Impairment of overall quality of life (mean score of 7 domains) during the pollen season was less in the immunotherapy group than in the placebo group (median difference [95% CI], 0.8 [0.18-1.5]; P=.05=2]. During the pollen season, there was no change in airway methacholine PC20 (provocation concentration producing a 20% fall in FEV1) in the immunotherapy-treated group (P=5), compared with an almost 3 doubling-dose decrease in the placebo-treated group (P=.5), compared with an almost 3 doubling dose decrease in the placebo-treated group (P=.01, between-group difference). There were no significant local or systemic side effects during the study.
Conclusion: Grass pollen immunotherapy improves quality of life in seasonal allergic rhinitis and reduces seasonal asthma symptoms and bronchial hyperresponsiveness.
Note: Ongoing mechanistic studies and nasal biopsies studies until 2008
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male and female 18-60 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 ≥ 5 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 |
|---|---|---|
| Subcutaneous Alutard SQ grass pollen (Phleum pratense) | Biological | – |
| Venepuncture: 20 ml blood sample taken on 2 separate visits | Procedure or surgery | – |
Primary outcome
Symptom and medication score recorded by subjects
Adverse events
3 secondary outcomes
Rhinoconjunctivitis Quality of Life Questionnaire
Seasonal bronchial hyperresponsiveness
Intradermal allergen challenge
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 14 Sep 2023.
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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, NHLI Imperial College London United Kingdom
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 Subcutaneous Alutard SQ grass pollen (Phleum pratense) and Venepuncture: 20 ml blood sample taken on 2 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 10 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 14 Sep 2023. 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. 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. 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?
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 14 Sep 2023.