Allergic RhinitisPhase 2GRAMALNCT02126111
Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis
A Phase 2 study testing DEPIGOID phleum in people with Allergic Rhinitis, run by Plaza del Hospital Civil at 2 sites in Spain.
Trial summary
The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- DEPIGOID phleum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2010to Apr 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Local allergic rhinitis with sensitization to grass pollen
- Skin prick test and serum specific IgE negative to grass pollen.
- Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
- Written informed consent
Who cannot join
- Immunological diseases
- Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
- Treatment with beta-blockers
- Severe psychological disorders
- Severe atopic dermatitis
- FEV1 < 70% of reference value after treatment
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- Hypersensitivity or intolerance to excipients and / or medication trial.
- Failure to adequately perform diagnostic tests or treatment.
- Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response.
- Immunotherapy in the 5 years prior to their inclusion in the study.
- Pregnant women or at risk of pregnancy and lactating women.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Infanta Leonor
Madrid, Madrid
Hospital Regional Universitario Carlos Haya
Málaga, Malaga
About this study
Official title: Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis
The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- DEPIGOID phleum, DEPIGOID Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEPIGOID phleumBiological
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
DEPIGOID PlaceboBiological
Placebo for subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| DEPIGOID phleum | Active comparator | The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection. Receives: Biological: DEPIGOID phleum |
| DEPIGOID Placebo & DEPIGOID Phleum | Placebo comparator | This arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study.
DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract. Receives: Biological: DEPIGOID phleum; Biological: DEPIGOID Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and medication scores comparison between active and placebo group
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs.
Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe).
The use of rescue medication was recorded in the patient diary according to the following score:
Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
Measured: two years
Secondary outcomes (10)
Response to nasal allergen provocation test with phleum (NAPT-Phl)
The response to NAPT-Phl with increasing concentrations of phleum pratense (0.001-0.01-0.05-0.1 mcg/ml) will be evaluated by nasal symptoms and acoustic rhinometry.
Measured: two years
Skin prick-test (SPT) with phleum.
Evaluation of SPT wheal size.
Measured: 2 years
Intradermal test (IDT) with phleum
IDT wheal and erythema size.
Measured: 2 years
FEV1
Measured: 2 years
Quality of life questionnaire RQLQ
Measured: 2 years
Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage
Measured: 2 years
Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.
Measured: 2 years
Heart rate
Measured: 2 years
Blood pressure
Measured: 2 years
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 posted29 Apr 2014 (estimated)
- Study startOct 2010
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plaza del Hospital Civil
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios Leti, S.L.
- Responsible party
- Principal investigator, Miguel Blanca Gomez, Plaza del Hospital Civil
- Investigators
- Miguel Blanca, MD, PhD, Principal investigator, Hospital Regional Universitario, Málaga, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126111
- Sponsor's protocol ID
- MBG6043179
- Acronym
- GRAMAL
- Status last verified
- Nov 2016
- First submitted
- 12 Feb 2014
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.
PubMed 29168570
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02126111
- Acronym / sponsor ID
- GRAMAL / MBG6043179
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Plaza del Hospital CivilUniversity, hospital or other
- Collaborators
- Laboratorios Leti, S.L.
- Study start
- Oct 2010
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Apr 2014 (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 is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEPIGOID phleum | Active comparator | Biological: DEPIGOID phleumThe active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection. |
| DEPIGOID Placebo & DEPIGOID Phleum | Placebo comparator | Biological: DEPIGOID phleum, Biological: DEPIGOID PlaceboThis arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study. DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Local allergic rhinitis with sensitization to grass pollen
- Skin prick test and serum specific IgE negative to grass pollen.
- Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
- Written informed consent
Key exclusion criteria (11 listed)
- Immunological diseases
- Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
- Treatment with beta-blockers
- Severe psychological disorders
- Severe atopic dermatitis
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 |
|---|---|---|
| DEPIGOID phleumSubcutaneous Immunotherapy with modified extract of Phleum pollen. | Biological | DEPIGOID Placebo & DEPIGOID Phleum, DEPIGOID phleum |
| DEPIGOID PlaceboPlacebo for subcutaneous administration | Biological | DEPIGOID Placebo & DEPIGOID Phleum |
Primary outcome
Symptoms and medication scores comparison between active and placebo group
Time frame: two years
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
10 secondary outcomes
Response to nasal allergen provocation test with phleum (NAPT-Phl)
Time frame: two years
Skin prick-test (SPT) with phleum.
Time frame: 2 years
Intradermal test (IDT) with phleum
Time frame: 2 years
FEV1
Time frame: 2 years
Quality of life questionnaire RQLQ
Time frame: 2 years
Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage
Time frame: 2 years
Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.
Time frame: 2 years
Heart rate
Time frame: 2 years
Blood pressure
Time frame: 2 years
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 8 Nov 2016.
- Derived from this study: PubMed 29168570Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.
- Individual participant dataSharing planned: No
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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.
Miguel Blanca, MD, PhD principal investigator
Hospital Regional Universitario, Málaga, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DEPIGOID phleum in people with Allergic Rhinitis, run by Plaza del Hospital Civil at 2 sites 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 4 inclusion and 11 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Symptoms and medication scores comparison between active and placebo group (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126111, which also lists 1 linked publication.
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 8 Nov 2016.