Allergic RhinoconjunctivitisPhase 2GPITNCT00550875
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis
A Phase 2 study testing Grass pollen allergenic extract (L. perenne-C. dactylon ) in people with Allergic Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 1 site in South Africa.
Trial summary
As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Grass pollen allergenic extract (L. perenne-C. dactylon )
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2007to Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical history of allergic rhinoconjunctivitis and/or asthma due to hypersensitivity to grass mix Lolium perenne and Cynodon dactylon.
- Male or female subjects between 18 and 50 years old
- Positive skin tests to Lolium perenne and Cynodon dactylon: the wheal produced by the skin test by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
- Presence of specific IgE to Lolium perenne and Cynodon dactylon (CAP greater than 17.5K u/L).
- Female subjects must not be sexually active or must be following a medially accepted contraceptive method.
- Pregnancy test negative
Who cannot join
- Treatment with ß-blocking agents
- Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
- Autoimmune disease (thyroiditis, lupus, etc.)
- Conditions in which the patient can not offer full co-operation, compliance or those with significant psychiatric disturbance.
- Intolerance to aspirin.
- Pregnant women or with pregnancy risk and breast-feeding women
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Allergy Unit, UCT Lung Institute
Mowbray, Cape Town, 7700
About this study
Official title: A Randomised Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Sublingual Immunotherapy With a Depigmented and Polymerized Grass Pollen Extracts in Patients Suffering From Allergic Rhinoconjunctivitis.
As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be instructed to daily assess each one of the symptoms, recording them on an individual symptoms follow-up diary.
Read the detailed description
The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as drops under the tongue. At the beginning of the study, you will be given a card that documents that you are taking part. Please carry this with you at all times, in case treatment is necessary at another location. The drops will be given at two doses. The drops are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis (nasal allergy and allergy of the eyes).
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Grass pollen allergenic extract (L. perenne-C. dactylon ), placebo
- Keywords
- Allergic rhinoconjunctivitis,, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grass pollen allergenic extract (L. perenne-C. dactylon )Biological
Sublingual. 2 drops/daily 1000 DPP/ml 2 years
Grass pollen allergenic extract (L. perenne-C. dactylon )Biological
Sublingual. 2 drops/daily 10000 DPP/ml 2 years
placeboBiological
Sublingual. 2 drops/daily 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) |
| 2 | Experimental | 10* concentration of arm 1 Receives: Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) |
| 3 | Placebo comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC for Symptom Score and Mean Symptom Score in the pollen period.
Measured: 2 years
Secondary outcomes (1)
Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinoconjunctivitisStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Leti, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Potter, PhD, Prof., Principal investigator, UCT Lung Institute, Cape Town, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550875
- Sponsor's protocol ID
- 6078-PG-OSL-137
- Acronym
- GPIT
- Status last verified
- Jul 2011
- First submitted
- 22 Aug 2007
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Sublingual Immunotherapy With a Depigmented and Polymerized Grass Pollen Extracts in Patients Suffering From Allergic Rhinoconjunctivitis.
- ClinicalTrials.gov ID
- NCT00550875
- Acronym / sponsor ID
- GPIT / 6078-PG-OSL-137
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinoconjunctivitis,, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Laboratorios Leti, S.L.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Oct 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.
As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be instructed to daily assess each one of the symptoms, recording them on an individual symptoms follow-up diary.
Detailed description
The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as drops under the tongue. At the beginning of the study, you will be given a card that documents that you are taking part. Please carry this with you at all times, in case treatment is necessary at another location. The drops will be given at two doses. The drops are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis (nasal allergy and allergy of the eyes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ) |
| 2 | Experimental | Biological: Grass pollen allergenic extract (L. perenne-C. dactylon )10* concentration of arm 1 |
| 3 | Placebo comparator | Biological: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical history of allergic rhinoconjunctivitis and/or asthma due to hypersensitivity to grass mix Lolium perenne and Cynodon dactylon.
- Male or female subjects between 18 and 50 years old
- Positive skin tests to Lolium perenne and Cynodon dactylon: the wheal produced by the skin test by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
- Presence of specific IgE to Lolium perenne and Cynodon dactylon (CAP greater than 17.5K u/L).
- Female subjects must not be sexually active or must be following a medially accepted contraceptive method.
Key exclusion criteria (6 listed)
- Treatment with ß-blocking agents
- Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
- Autoimmune disease (thyroiditis, lupus, etc.)
- Conditions in which the patient can not offer full co-operation, compliance or those with significant psychiatric disturbance.
- Intolerance to aspirin.
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 |
|---|---|---|
| Grass pollen allergenic extract (L. perenne-C. dactylon )Sublingual. 2 drops/daily 1000 DPP/ml 2 years | Biological | 1 |
| Grass pollen allergenic extract (L. perenne-C. dactylon )Sublingual. 2 drops/daily 10000 DPP/ml 2 years | Biological | 2 |
| placeboSublingual. 2 drops/daily 2 years | Biological | 3 |
Primary outcome
AUC for Symptom Score and Mean Symptom Score in the pollen period.
Time frame: 2 years
1 secondary outcome
Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events
Time frame: 2 years
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 13 Jul 2011.
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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.
Paul Potter, PhD, Prof. principal investigator
UCT Lung Institute, Cape Town, South Africa
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 Grass pollen allergenic extract (L. perenne-C. dactylon ) in people with Allergic Rhinoconjunctivitis, run by Laboratorios Leti, S.L. at 1 site in South Africa.
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 6 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 13 Jul 2011. 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 South Africa. 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?
AUC for Symptom Score and Mean Symptom Score in the pollen period. (time frame: 2 years). 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 13 Jul 2011.