Seasonal Allergic RhinitisPhase 3NCT00916422
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
A Phase 3 study testing Allergen extract (Phleum pratense) in people with Seasonal Allergic Rhinitis, run by Laboratorios Leti, S.L. at 23 sites in 2 countries.
Trial summary
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense pollen in the treatment of patients affected by allergic rhinitis/ rhinoconjunctivitis ( with or without episodic asthma) induced by… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Allergen extract (Phleum pratense)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Jun 2008to Oct 2013
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent, signed by the subject.
- Clinical History of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen.
- Patient of both gender aged from 18 up to 55
- Symptoms that coincide with allergy to grass pollen
- Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: Positive prick test and /or Specific IgE to P.pratense >0,7KU/L Patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to p.pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint.
- Patients who are able to comply with the dose regime
Who cannot join
- Patient with mild Rhinitis/rhinoconjunctivitis
- Relevant sensitivity to another perennial allergen
- Use of immunotherapy during the last four years
- Treatment with B. Blocking agents
- Patient suffering from some pathology in which adrenalin was contraindicated
- Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
Show all 10Show fewer
- Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
- Conditions in which the patient can not offer full co-operation and significant psychiatric disorders.
- Intolerance to aspirin
- Pregnant women or with pregnancy risk and breast-feeding
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Spain19 sites
Hospital Ntra. Sra de Sonsoles
Ávila
Hospital de Llerena
Badajoz
Hospital Militar de Burgos
Burgos
Hospital de Coria
Cáceres
Hospital Ntra. Sra. de la Montaña
Cáceres
Hospital Ciudad Real
Ciudad Real
Hospital San Juan de Dios
León
Hospital Virgen Blanca
León
Hospital San Millan
Logroño
Hospital Universitario de Getafe
Madrid, Madrid, 28905
Hospital de Merida
Mérida
Clinica Universitaria de Navarra
Navarra
H. Río Carrión
Palencia, Palencia, 34005
Hospital del Bierzo
Ponferrada
Hospital Santa Barbara
Puertollano
Hospital de Santa Barbara
Soria
Hospital Universitario del Río Hortega
Valladolid
Hospital Clinico Lozano Blesa
Zaragoza
Hospital la Maz
Zaragoza
Hungary4 sites
Fövarosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített
Budapest, Budapest, 1122
AEK Jarobetegszakrendelo Intézet Pulmonologia
Budapest, Budapest, 1134
Selye jános Kórhaz-Rendelöintézet Tüdögondozó Intézet
Komárom, Komárom, 2900
Karolina Kórhaz Rendelöintézet Tüdögondozó
Mosonmagyaróvár, Mosonmagyaróvár, 9200
About this study
Official title: Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass Pollen
The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense pollen in the treatment of patients affected by allergic rhinitis/ rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the Score regarding Symptoms and consumption of the medication.
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 two arms of treatment in an up-dosing cluster regimen for 4 weeks.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Allergen extract (Phleum pratense), Placebo
- Keywords
- Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, 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.
Allergen extract (Phleum pratense)Biological
Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.
PlaceboBiological
Subcutaneous monthly treatment
| Study group | Role | What they receive |
|---|---|---|
| Depigoid Phleum pratense 1000DPP/Ml | Experimental | Depigmented and Polymerized Allergen extract of Phleum Pratense.Subcutaneous Immunotherapy in an up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. Receives: Biological: Allergen extract (Phleum pratense) |
| 2 | Placebo comparator | Placebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and medication score recorded by subjects
Measured: 2 year
Secondary outcomes (1)
Nasal provocation test, Dose-response skin prick test, Rhinoconjunctivitis Quality of life questionnaire, visual scales, asthma symptom scores, medication scores, adverse event and severity adverse event, unplanned health care resource utilization
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandro Sanchez, Principal investigator, Hospital Río Carrión
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916422
- Sponsor's protocol ID
- 2006-005868-10
- Status last verified
- Aug 2012
- First submitted
- 5 Jun 2009
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Multi-centre,Randomized, Double-blind, Placebo-controlled Subcutaneous Immunotherapy Trial With Depigmented, Polymerised Extract of Phleum Pratense Pollen on Patients With Hypersensitivity to Grass Pollen
- ClinicalTrials.gov ID
- NCT00916422
- Acronym / sponsor ID
- 2006-005868-10
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Jun 2009 (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 assess the clinical efficacy of the modified extract (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum pratense pollen in the treatment of patients affected by allergic rhinitis/ rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the Score regarding Symptoms and consumption of the medication.
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 two arms of treatment in an up-dosing cluster regimen for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depigoid Phleum pratense 1000DPP/Ml | Experimental | Biological: Allergen extract (Phleum pratense)Depigmented and Polymerized Allergen extract of Phleum Pratense.Subcutaneous Immunotherapy in an up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years. |
| 2 | Placebo comparator | Biological: PlaceboPlacebo. Dosing regimen: An up-dosing cluster regimen for 4 weeks, followed by monthly injections for 2 years |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent, signed by the subject.
- Clinical History of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen.
- Patient of both gender aged from 18 up to 55
- Symptoms that coincide with allergy to grass pollen
- Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: Positive prick test and /or Specific IgE to P.pratense >0,7KU/L Patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to p.pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint.
Key exclusion criteria (10 listed)
- Patient with mild Rhinitis/rhinoconjunctivitis
- Relevant sensitivity to another perennial allergen
- Use of immunotherapy during the last four years
- Treatment with B. Blocking agents
- Patient suffering from some pathology in which adrenalin was contraindicated
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 |
|---|---|---|
| Allergen extract (Phleum pratense)Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment. | Biological | Depigoid Phleum pratense 1000DPP/Ml |
| PlaceboSubcutaneous monthly treatment | Biological | 2 |
Primary outcome
Symptoms and medication score recorded by subjects
Time frame: 2 year
1 secondary outcome
Nasal provocation test, Dose-response skin prick test, Rhinoconjunctivitis Quality of life questionnaire, visual scales, asthma symptom scores, medication scores, adverse event and severity adverse event, unplanned health care resource utilization
Time frame: 2
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 29 Jan 2014.
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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.
Alejandro Sanchez principal investigator
Hospital Río Carrión
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allergen extract (Phleum pratense) in people with Seasonal Allergic Rhinitis, run by Laboratorios Leti, S.L. at 23 sites in 2 countries.
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 10 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain, Hungary. 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?
Symptoms and medication score recorded by subjects (time frame: 2 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 29 Jan 2014.