Rhinitis, Allergic, SeasonalPhase 2NCT00501527
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
A Phase 2 study testing Immunotherapy with modified extract of P. pratense pollen in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by Laboratorios Leti, S.L. at 1 site in Spain.
Trial summary
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma
- What is being tested?
- Immunotherapy with modified extract of P. pratense pollen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Oct 2009
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Positive clinical history of allergy to Phleum pratense
- Patients of both gender aged from 12 up to 50 years.
- Positive prick test to Phleum pratense allergen extracts
- Specific IgE to Phleum pratense
- Positive clinical history of allergic rhinoconjunctivitis and/or asthma
- Written informed consent.
Who cannot join
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- Patients suffering from immune deficiencies
- Patients with serious psychiatric / psychological disturbances
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- In addition, the following was considered as exclusion criteria:
- Pregnant or/ in lactation patients
- Patients aspirin intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
Read the detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
- Being tested
- Immunotherapy with modified extract of P. pratense pollen, Placebo
- Keywords
- Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy with modified extract of P. pratense pollenBiological
Sublingual (2 drops daily)
PlaceboOther
Placebo 2 drops daily
| Study group | Role | What they receive |
|---|---|---|
| A: Biological vaccine | Experimental | The first active arm will receive a dose that is 10x less than the dose of the other arm Receives: Biological: Immunotherapy with modified extract of P. pratense pollen |
| B: biological vaccine | Experimental | The first active arm will receive a dose that is 10x more than the dose of the other arm Receives: Biological: Immunotherapy with modified extract of P. pratense pollen |
| C | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scores
Measured: 1 year
Secondary outcomes (7)
Nasal provocation test
Measured: 1 year
Dose-response skin prick-test
Measured: 1 year
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Measured: 1 year
Medication scores
Measured: 1 year
Visual scales
Measured: 1 year
"In vitro" immunological tests
Measured: 1 year
Record of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2009
- Study completionOct 2009
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.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Félix Lorente, Prf. PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501527
- Sponsor's protocol ID
- 2006-001437-18
- Other IDs
- 6078-PG-OSL-145
- Status last verified
- Dec 2010
- First submitted
- 13 Jul 2007
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma
- ClinicalTrials.gov ID
- NCT00501527
- Acronym / sponsor ID
- 2006-001437-18
- Keywords
- Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Jul 2007 (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 objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
Detailed description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Biological vaccine | Experimental | Biological: Immunotherapy with modified extract of P. pratense pollenThe first active arm will receive a dose that is 10x less than the dose of the other arm |
| B: biological vaccine | Experimental | Biological: Immunotherapy with modified extract of P. pratense pollenThe first active arm will receive a dose that is 10x more than the dose of the other arm |
| C | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Positive clinical history of allergy to Phleum pratense
- Patients of both gender aged from 12 up to 50 years.
- Positive prick test to Phleum pratense allergen extracts
- Specific IgE to Phleum pratense
- Positive clinical history of allergic rhinoconjunctivitis and/or asthma
Key exclusion criteria (9 listed)
- Use of immunotherapy during the last four years.
- Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
- Treatment with ß-blockers
- Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
- Patients suffering from immune deficiencies
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 |
|---|---|---|
| Immunotherapy with modified extract of P. pratense pollenSublingual (2 drops daily) | Biological | A: Biological vaccine, B: biological vaccine |
| PlaceboPlacebo 2 drops daily | Other | C |
Primary outcome
Symptom scores
Time frame: 1 year
7 secondary outcomes
Nasal provocation test
Time frame: 1 year
Dose-response skin prick-test
Time frame: 1 year
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time frame: 1 year
Medication scores
Time frame: 1 year
Visual scales
Time frame: 1 year
"In vitro" immunological tests
Time frame: 1 year
Record of adverse events
Time frame: 1 year
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 17 Dec 2010.
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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.
Félix Lorente, Prf. PhD principal investigator
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 Immunotherapy with modified extract of P. pratense pollen in people with Rhinitis, Allergic, Seasonal and Conjunctivitis, Allergic, run by Laboratorios Leti, S.L. at 1 site in Spain.
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 6 inclusion and 9 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 17 Dec 2010. 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 Spain. 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?
Symptom scores (time frame: 1 year). 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 17 Dec 2010.