Allergic RhinoconjunctivitisPhase 1NCT01489033
Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
A Phase 1 study testing Subcutaneous immunotherapy with Phleum pratense pollen extract in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A at 1 site in Spain.
Trial summary
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum… 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?
- Subcutaneous immunotherapy with Phleum pratense pollen extract
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to May 2010
- Phase
- Phase 1
- 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
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to Phleum pratense.
- Patients with seasonal allergic rhinoconjunctivitis against Phleum pratense during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild or moderate concomitant asthma is allowed.
- Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients to other seasonal allergens will be accepted if sensitizations are caused by Pollens whose seasons do not overlap with Phleum pratense.
- Polysensitized patients to perennial allergens will also be accepted if not clinically relevant during the study period.
- Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
- Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.
Who cannot join
- Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- Patients sensitised to other overlapping seasonal allergens and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- Patients who received immunotherapy in the previous 5 years for Phleum pratense or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or FEV1 lower than 60% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment commencement.
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- Patients with a previous history of anaphylaxis
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- Patients with unstable angina
- Patients with uncontrolled hypertension
- Patients with clinically significant arrythmias
- Patients with neoplasia
- Patients with clinically relevant malformations of the upper respiratory tract.
- Other chronic or immunological disease that could interfere with the assessment of the investigation product or that could generate any additional risk for the patient
- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- Patients under treatment with tricyclic antidepressives, psychotropics or beta-blockers
- Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgical sterilised or present any other incapacity to bear
- Patient who does not attend the visits
- Patient's lack of collaboration or refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Phleum Pratense.
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Subcutaneous immunotherapy with Phleum pratense pollen extract
- Keywords
- Allergic rhinitis, Phleum pratense, Timothy grass pollen allergy, subcutaneous immunotherapy
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous immunotherapy with Phleum pratense pollen extractBiological
Increasing doses up to a maximum dose of 500 TSU
| Study group | Role | What they receive |
|---|---|---|
| Group A active | Experimental | 6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
| Group A placebo | Placebo comparator | 6 administrations and 5 weeks duration
1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
| Group B active | Experimental | 8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
| Group B placebo | Placebo comparator | 8 administrations and 7 weeks duration
1. Vial 1: 0.2 ml at 1 week intervals
2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
| Group C active | Experimental | 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
| Group C placebo | Placebo comparator | 8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval Receives: Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and seriousness of both local and systemic adverse reactions
Measured: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Secondary outcomes (1)
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response
Measured: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionMay 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxall Medicina España S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilio Álvarez-Cuesta, Md, PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489033
- Sponsor's protocol ID
- BIA-PHL-P1-001
- Other IDs
- 2009-015000-26, 2009
- Status last verified
- Apr 2017
- First submitted
- 7 Dec 2011
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Phleum Pratense.
- ClinicalTrials.gov ID
- NCT01489033
- Acronym / sponsor ID
- BIA-PHL-P1-001
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic rhinitis, Phleum pratense, Timothy grass pollen allergy, subcutaneous immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Roxall Medicina España S.AIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Dec 2011 (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.
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A active | Experimental | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. |
| Group A placebo | Placebo comparator | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals. |
| Group B active | Experimental | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals |
| Group B placebo | Placebo comparator | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals |
| Group C active | Experimental | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval |
| Group C placebo | Placebo comparator | Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to Phleum pratense.
- Patients with seasonal allergic rhinoconjunctivitis against Phleum pratense during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild or moderate concomitant asthma is allowed.
- Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients to other seasonal allergens will be accepted if sensitizations are caused by Pollens whose seasons do not overlap with Phleum pratense.
Key exclusion criteria (17 listed)
- Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- Patients sensitised to other overlapping seasonal allergens and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- Patients who received immunotherapy in the previous 5 years for Phleum pratense or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- Patients with severe asthma or FEV1 lower than 60% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment commencement.
- Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
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 immunotherapy with Phleum pratense pollen extractIncreasing doses up to a maximum dose of 500 TSU | Biological | Group A active, Group A placebo, Group B active, Group B placebo, Group C active, Group C placebo |
Primary outcome
Number and seriousness of both local and systemic adverse reactions
Time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
1 secondary outcome
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
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 1 May 2017.
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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.
Emilio Álvarez-Cuesta, Md, PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Subcutaneous immunotherapy with Phleum pratense pollen extract in people with Allergic Rhinoconjunctivitis, run by Roxall Medicina España S.A 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 8 inclusion and 17 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 1 May 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and seriousness of both local and systemic adverse reactions (time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )). 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 1 May 2017.