RhinitisPhase 2MG56NCT02654223
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
A Phase 2 study testing MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous and MG56 Mannosylated 3000 subcutaneous in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 12 sites in Spain.
Trial summary
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Rhinitis, Rhinoconjunctivitis
- What is being tested?
- MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous and MG56 Mannosylated 3000 subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 12 sitesSpain
- Study dates
- 30 Dec 2015to Nov 2021
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to grass pollen allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) Specific immunoglobulin E (IgE, CAP >3) to grass pollen
- Age between 14 and 65 years
- Both genders
- Subjects capable of giving informed consent
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- Subjects capable of complying with the dosing regimen
- Subjects that have not received immunotherapy in the last 5 years
- Subjects presenting sensitization to another aeroallergens and or mites, cats or dogs, but that is considered clinically not relevant or no clinical interference with the nasal provocation test.
Who cannot join
- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (FEV) < 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
- Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial.
Show all 18Show fewer
- Subjects that have previously submitted a serious secondary reaction during the skin prick test
- Subjects in treatment with beta blockers.
- Unstable subjects from the clinical point of view (respiratory infection, febrile, acute urticaria, etc.) at the time of the inclusion in the clinical trial
- Subject with chronic urticaria in the last 2 years or hereditary angioedema.
- Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.
- Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, diabetes, malformations, multi-operated, kidney diseases,...).
- Subjects with autoimmune disease (lupus, thyroiditis, etc.), tumor or with diagnosis of immunodeficiency diseases.
- Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders.
- Subject with known allergy to other components of the vaccine different from pollen of grasses.
- Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
- Direct investigator's relatives.
- Pregnant or women at risk of pregnancy and breastfeeding women.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Clínica Atlas
Aranjuez, Madrid, 28300
Hospital Nisa Aljarafe
Castilleja de la Cuesta, Sevilla, 41950
Hospital San Agustín
Dos Hermanas, Sevilla, 41703
CLÍNICA Dr. SUBIZA
Madrid, 28006
Clínica Ojeda
Madrid, 28006
Hospital Universitario Ramón y Cajal
Madrid, 28034
HOSPITAL UNIVERSITARIO 12 de OCTUBRE
Madrid, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Viamed Santa Angola de la Cruz
Seville, 41013
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342
Clínica Alianza Médica
Valladolid, 47001
About this study
Official title: Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
Read the detailed description
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
- Conditions
- Rhinitis, Rhinoconjunctivitis
- Being tested
- MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous, MG56 Mannosylated 3000 subcutaneous, MG56 Mannosylated 5000 subcutaneous, MG56 Mannosylated 500 sublingual
- Keywords
- Rhinitis / Rhinoconjunctivitis, Vaccine, Immunotherapy, Grass pollen, Allergy
- Medical subject headings
- Rhinitis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG56 Mannosylated 500 subcutaneousBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
MG56 Mannosylated 1000 subcutaneousBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
MG56 Mannosylated 3000 subcutaneousBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
MG56 Mannosylated 5000 subcutaneousBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous
MG56 Mannosylated 500 sublingualBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual
MG56 Mannosylated 1000 sublingualBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual
MG56 Mannosylated 3000 sublingualBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual
MG56 Mannosylated 5000 sublingualBiological
Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual
Subcutaneous placeboBiological
Comparison between placebo and active group
Sublingual placeboBiological
Comparison between placebo and active group
| Study group | Role | What they receive |
|---|---|---|
| MG56 Mannosylated 500 subcutaneous | Experimental | 500 mTU/mL of subcutaneous immunotherapy and sublingual placebo. Receives: Biological: MG56 Mannosylated 500 subcutaneous; Biological: Sublingual placebo |
| MG56 Mannosylated 1000 subcutaneous | Experimental | 1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. Receives: Biological: MG56 Mannosylated 1000 subcutaneous; Biological: Sublingual placebo |
| MG56 Mannosylated 3000 subcutaneous | Experimental | 3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. Receives: Biological: MG56 Mannosylated 3000 subcutaneous; Biological: Sublingual placebo |
| MG56 Mannosylated 5000 subcutaneous | Experimental | 5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. Receives: Biological: MG56 Mannosylated 5000 subcutaneous; Biological: Sublingual placebo |
| MG56 Mannosylated 500 sublingual | Experimental | 500 mTU/mL of sublingual immunotherapy and subcutaneous placebo. Receives: Biological: MG56 Mannosylated 500 sublingual; Biological: Subcutaneous placebo |
| MG56 Mannosylated 1000 sublingual | Experimental | 1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. Receives: Biological: MG56 Mannosylated 1000 sublingual; Biological: Subcutaneous placebo |
| MG56 Mannosylated 3000 sublingual | Experimental | 3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. Receives: Biological: MG56 Mannosylated 3000 sublingual; Biological: Subcutaneous placebo |
| MG56 Mannosylated 5000 sublingual | Experimental | 5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. Receives: Biological: MG56 Mannosylated 5000 sublingual; Biological: Subcutaneous placebo |
| Placebo Sublingual Placebo subcutaneous | Placebo comparator | Sublingual and subcutaneous placebo. Receives: Biological: Subcutaneous placebo; Biological: Sublingual placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration required to elicit a positive response after nasal provocation test (NPT)
Change in the threshold concentration of grass allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry.
This will be compared between the beginning and end of the trial and among active groups and placebo.
Measured: 4 months
Secondary outcomes (5)
Dose finding skin prick test
Comparison between the beginning and end of the trial and among active groups and placebo
Measured: 4 months
Cytokine production by T cells specific allergen
Comparison between the beginning and end of the trial and among active groups and placebo
Measured: 4 months
Immunoglobulin production by B cells specific allergen
Comparison between the beginning and end of the trial and among active groups and placebo
Measured: 4 months
Phenotypic and functional analysis of dendritic cells
Will be analyzed changes in the frequency of plasmacytoid dendritic cells, myeloid dendritic cell and Treg cells in peripheral blood, between the beginning and end of the trial and among active groups and placebo
The frequencies of peripheral blood mononuclear cells in each of the above populations is determined before and after treatment with mannosylated polymers by flow cytometry after staining with specific antibodies.
Measured: 4 months
Number of participants with treatment-related adverse events as assessed by MG56-SIT-012
Comparison between the beginning and end of the trial and among active groups and placebo
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study start30 Dec 2015
- Primary completionNov 2021
- Study completionNov 2021
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 RhinitisStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Subiza, PhD; MD, Principal investigator, Clinica SublizaCarmen Diéguez, PhD; MD, Principal investigator, Hospital Universitario 12 de OctubrePedro Ojeda, PhD; MD, Study director, Clínica OjedaJavier Ruiz Hornillos, PhD; MD, Principal investigator, Hospital Universitario Infanta ElenaMatilde Domínguez, PhD; MD, Principal investigator, Hospital Universitario Puerta de HierroEmilio Solano, MD, Principal investigator, Hospital Universitario Ramon y CajalAntonio Moreno, Principal investigator, Clínica AtlasPedro Guardia, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654223
- Sponsor's protocol ID
- MG56-SIT-012
- Other IDs
- 2014-005471-88, 2014
- Acronym
- MG56
- Status last verified
- Jan 2022
- First submitted
- 22 Dec 2015
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ojeda P, Barjau MC, Subiza J, Moreno A, Ojeda I, Solano E, Alonso A, Caballero R, Del Pozo S, Gomez-Perosanz M, Sanchez-Trincado JL, Benito-Villalvilla C, Angelina A, Soria I, Reche PA, Palomares O, Subiza JL, Casanovas M. Grass pollen allergoids conjugated with mannan for subcutaneous and sublingual immunotherapy: a dose-finding study. Front Immunol. 2024 Jun 26;15:1431351. doi: 10.3389/fimmu.2024.1431351. eCollection 2024.
PubMed 38989287
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo-controlled, Dose Finding, Prospective, Multicenter Clinical Trial for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
- ClinicalTrials.gov ID
- NCT02654223
- Acronym / sponsor ID
- MG56 / MG56-SIT-012
- Conditions
- Rhinitis, Rhinoconjunctivitis
- Keywords
- Rhinitis / Rhinoconjunctivitis, Vaccine, Immunotherapy, Grass pollen, Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2015 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 13 Jan 2016 (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 the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
Detailed description
Double blind placebo-controlled study. The subjects will receive medication during 4 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| MG56 Mannosylated 500 subcutaneous | Experimental | Biological: MG56 Mannosylated 500 subcutaneous, Biological: Sublingual placebo500 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
| MG56 Mannosylated 1000 subcutaneous | Experimental | Biological: MG56 Mannosylated 1000 subcutaneous, Biological: Sublingual placebo1000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
| MG56 Mannosylated 3000 subcutaneous | Experimental | Biological: MG56 Mannosylated 3000 subcutaneous, Biological: Sublingual placebo3000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
| MG56 Mannosylated 5000 subcutaneous | Experimental | Biological: MG56 Mannosylated 5000 subcutaneous, Biological: Sublingual placebo5000 mTU/mL of subcutaneous immunotherapy and sublingual placebo. |
| MG56 Mannosylated 500 sublingual | Experimental | Biological: MG56 Mannosylated 500 sublingual, Biological: Subcutaneous placebo500 mTU/mL of sublingual immunotherapy and subcutaneous placebo. |
| MG56 Mannosylated 1000 sublingual | Experimental | Biological: MG56 Mannosylated 1000 sublingual, Biological: Subcutaneous placebo1000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. |
| MG56 Mannosylated 3000 sublingual | Experimental | Biological: MG56 Mannosylated 3000 sublingual, Biological: Subcutaneous placebo3000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. |
| MG56 Mannosylated 5000 sublingual | Experimental | Biological: MG56 Mannosylated 5000 sublingual, Biological: Subcutaneous placebo5000 mTU/mL of sublingual immunotherapy and subcutaneous placebo. |
| Placebo Sublingual Placebo subcutaneous | Placebo comparator | Biological: Subcutaneous placebo, Biological: Sublingual placeboSublingual and subcutaneous placebo. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to grass pollen allergy
- Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) Specific immunoglobulin E (IgE, CAP >3) to grass pollen
- Age between 14 and 65 years
- Both genders
Key exclusion criteria (18 listed)
- Subjects outside of the age range.
- Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to grass pollen and other allergens in the last 5 years.
- Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include.
- Subjects with important symptoms of rhinoconjunctivitis /bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.
- Subjects with persistent severe or not controlled asthma , with a forced expiratory volume (FEV) < 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial.
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 |
|---|---|---|
| MG56 Mannosylated 500 subcutaneousMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml subcutaneous | Biological | MG56 Mannosylated 500 subcutaneous |
| MG56 Mannosylated 1000 subcutaneousMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous | Biological | MG56 Mannosylated 1000 subcutaneous |
| MG56 Mannosylated 3000 subcutaneousMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous | Biological | MG56 Mannosylated 3000 subcutaneous |
| MG56 Mannosylated 5000 subcutaneousMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml subcutaneous | Biological | MG56 Mannosylated 5000 subcutaneous |
| MG56 Mannosylated 500 sublingualMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 mTU (Mannosylated Therapeutic Units)/ml sublingual | Biological | MG56 Mannosylated 500 sublingual |
| MG56 Mannosylated 1000 sublingualMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 1000 mTU (Mannosylated Therapeutic Units)/ml sublingual | Biological | MG56 Mannosylated 1000 sublingual |
| MG56 Mannosylated 3000 sublingualMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 3000 mTU (Mannosylated Therapeutic Units)/ml sublingual | Biological | MG56 Mannosylated 3000 sublingual |
| MG56 Mannosylated 5000 sublingualMixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 5000 mTU (Mannosylated Therapeutic Units)/ml sublingual | Biological | MG56 Mannosylated 5000 sublingual |
| Subcutaneous placeboComparison between placebo and active group | Biological | MG56 Mannosylated 1000 sublingual, MG56 Mannosylated 3000 sublingual, MG56 Mannosylated 500 sublingual, MG56 Mannosylated 5000 sublingual, Placebo Sublingual Placebo subcutaneous |
| Sublingual placeboComparison between placebo and active group | Biological | MG56 Mannosylated 1000 subcutaneous, MG56 Mannosylated 3000 subcutaneous, MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 5000 subcutaneous, Placebo Sublingual Placebo subcutaneous |
Primary outcome
Concentration required to elicit a positive response after nasal provocation test (NPT)
Time frame: 4 months
Change in the threshold concentration of grass allergen extract, measured in Histamine Equivalent Prick per ml (HEP/ml), needed to trigger a positive response after nasal provocation test (NPT) assessed by acoustic rhinometry. This will be compared between the beginning and end of the trial and among active groups and placebo.
5 secondary outcomes
Dose finding skin prick test
Time frame: 4 months
Cytokine production by T cells specific allergen
Time frame: 4 months
Immunoglobulin production by B cells specific allergen
Time frame: 4 months
Phenotypic and functional analysis of dendritic cells
Time frame: 4 months
Number of participants with treatment-related adverse events as assessed by MG56-SIT-012
Time frame: 4 months
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 27 Jan 2022.
- Derived from this study: PubMed 38989287Ojeda P, Barjau MC, Subiza J, Moreno A, Ojeda I, Solano E, Alonso A, Caballero R, Del Pozo S, Gomez-Perosanz M, Sanchez-Trincado JL, Benito-Villalvilla C, Angelina A, Soria I, Reche PA, Palomares O, Subiza JL, Casanovas M. Grass pollen allergoids conjugated with mannan for subcutaneous and sublingual immunotherapy: a dose-finding study. Front Immunol. 2024 Jun 26;15:1431351. doi: 10.3389/fimmu.2024.1431351. eCollection 2024.
- 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.
Javier Subiza, PhD; MD principal investigator
Clinica Subliza
Carmen Diéguez, PhD; MD principal investigator
Hospital Universitario 12 de Octubre
Pedro Ojeda, PhD; MD study director
Clínica Ojeda
12 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 MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous and MG56 Mannosylated 3000 subcutaneous in people with Rhinitis and Rhinoconjunctivitis, run by Inmunotek S.L. at 12 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 9 inclusion and 18 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Concentration required to elicit a positive response after nasal provocation test (NPT) (time frame: 4 months). 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 NCT02654223, 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 27 Jan 2022.