Allergic RhinitisNavigAITNCT07419230
Evaluation of a Digital Tool to Improve Aeroallergen Immunotherapy Adherence. NavigAITme Project
A study testing Active Adherence-booster App and Inactive Adherence-booster App in people with Allergic Rhinitis, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Active Adherence-booster App and Inactive Adherence-booster App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2026to 11 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of any age and sex
- Patients who have received their first prescription for a new aeroallergen immunotherapy treatment as part of their routine care for allergic rhinitis with or without asthma
- Patients who have been prescribed only a single immunotherapy product
- Patients who have been prescribed a commercially available product, from any company, for sublingual or subcutaneous administration
- Patients who have provided the first photograph of the product for which they are entering the study
Who cannot join
- Patients receiving AIT prescription for asthma only, and do not suffer allergic rhinitis
- Administration routes other than subcutaneous or sublingual
- Patients receiving AIT prescription for other indications, e.g., food or hymenoptera allergies
- Patients who have received immunotherapy in the last 3 years or are currently undergoing treatment with an AIT product other than the one being studied in the current project.
- Patients who have received prescription for two or more different immunotherapy products simultaneously
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, Madrid, 28010
Pablo Rodríguez del Río, +34915035900, prrio@yahoo.es
About this study
Official title: Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project
Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy/safety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life.
While overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age.
Surprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.
- Conditions
- Allergic Rhinitis
- Being tested
- Active Adherence-booster App, Inactive Adherence-booster App
- Keywords
- allergen immunotherapy, Respiratory allergy, Allergic rhinitis, Adherence, Implementation, Persistance, AIT, Mobile App, Real life study, mites, grass, pollen, animal dander, sublingual, subcutaneous, SLIT, SCIT
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Adherence-booster AppDevice
The Active Adherence-booster App includes an array of short messages that will be delivered to the active arm participants to tackle previously reported factors negatively influencing adherence in AIT, such as patient´s knowledge on Allergic rhinitis and AIT as well as administration and purchase reminders.
The App will also serve as electronic Case Report Form
Inactive Adherence-booster AppDevice
The Inactive Adherence-booster App does not include any of the messages or intervention of the Active version.
The App only serves as electronic Case Report Form
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | This is the arm of the study where patients will receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have two main objectives:
i) deliver the intervention, mainly messages to improve patient´s education on allergic conditions and Aeroallergen Immunotherapy as well as administration and purchase reminders.
ii) serve as electronic Case Report Form allowing patients providing feedback to inform study variables Receives: Device: Active Adherence-booster App |
| Control Group | Other | This is the arm of the study where patients will NOT receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have only one objective:
i) serve as electronic Case Report Form allowing patients providing feedback to inform study variables Receives: Device: Inactive Adherence-booster App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
Persistence definition: time from the moment of delivery of the first product, until the estimated time of completion of the last product delivered. This definition has been previously used in this field.
A difference of 15% between active and control groups will be considered as clinically meaningful, denoting success of the intervention
Measured: From entry to the end of study period at 3 years
Secondary outcomes (4)
Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group
Measured: From entry to the end of second year of study period
Comparing the proportion of subjects who maintain therapeutic persistence after completing 1 years of Immunotherapy treatment in the active group vs control group
Measured: From entry to the end of first year of study period
Comparing the therapeutic self-reported implementation between persistent subjects after completing 3 years of Immunotherapy in the active group vs. the control group
Self-reported implementation data will be collected using a 7 point scale, where 1 represents the best implementation possible (100% of doses correctly taken) and 7 represents treatment withdrawal (0% of doses taken). Intermediate implementation levels vary to complete the scale
Measured: From entry to the end of study period at 3 years
Comparing AIT discontinuation reasons in non-persistent patients (ie, withdrawing the treatment), after 3 years of study will be collected
Patients withdrawing AIT will be invited to select one or more reasons for treatment discontinuation: i) AIT Adverse Events, ii) Insufficient AIT efficacy, iii) Considering AIT sufficiently efficacious as to prematurely withdrawn the treatment, iv) AIT costs, v) Lack of sufficient baseline allergy severity as to have started the treatment, vi) AIT schedule interfering patient´s lifestyle, vii) Insufficient adherence, viii) AIT discontinuated by the patient´s allergist, ix) Other reasons
Measured: From entry to the end of study period at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start11 Mar 2026
- Primary completion11 Mar 2030 (estimated)
- Study completion11 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, national study
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
- Responsible party
- Principal investigator, Pablo Rodríguez del Rio, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419230
- Sponsor's protocol ID
- R-0010/25
- Acronym
- NavigAIT
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project
- ClinicalTrials.gov ID
- NCT07419230
- Acronym / sponsor ID
- NavigAIT / R-0010/25
- Conditions
- Allergic Rhinitis
- Keywords
- allergen immunotherapy, Respiratory allergy, Allergic rhinitis, Adherence, Implementation, Persistance, AIT, Mobile App
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 11 Mar 2030 (estimated)
- Study completion
- 11 Mar 2030 (estimated)
- First posted
- 18 Feb 2026 (actual)
- 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.
Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy/safety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life.
While overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age.
Surprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, national study
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: Active Adherence-booster AppThis is the arm of the study where patients will receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have two main objectives: i) deliver the intervention, mainly messages to improve patient´s education on allergic conditions and Aeroallergen Immunotherapy as well as administration and purchase reminders. ii) serve as electronic Case Report Form allowing patients providing feedback to inform study variables |
| Control Group | Other | Device: Inactive Adherence-booster AppThis is the arm of the study where patients will NOT receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have only one objective: i) serve as electronic Case Report Form allowing patients providing feedback to inform study variables |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of any age and sex
- Patients who have received their first prescription for a new aeroallergen immunotherapy treatment as part of their routine care for allergic rhinitis with or without asthma
- Patients who have been prescribed only a single immunotherapy product
- Patients who have been prescribed a commercially available product, from any company, for sublingual or subcutaneous administration
- Patients who have provided the first photograph of the product for which they are entering the study
Key exclusion criteria (5 listed)
- Patients receiving AIT prescription for asthma only, and do not suffer allergic rhinitis
- Administration routes other than subcutaneous or sublingual
- Patients receiving AIT prescription for other indications, e.g., food or hymenoptera allergies
- Patients who have received immunotherapy in the last 3 years or are currently undergoing treatment with an AIT product other than the one being studied in the current project.
- Patients who have received prescription for two or more different immunotherapy products simultaneously
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 |
|---|---|---|
| Active Adherence-booster AppThe Active Adherence-booster App includes an array of short messages that will be delivered to the active arm participants to tackle previously reported factors negatively influencing adherence in AIT, such as patient´s knowledge on Allergic rhinitis and AIT as well as administration and purchase reminders. The App will also serve as electronic Case Report Form | Device | Active Group |
| Inactive Adherence-booster AppThe Inactive Adherence-booster App does not include any of the messages or intervention of the Active version. The App only serves as electronic Case Report Form | Device | Control Group |
Primary outcome
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
Time frame: From entry to the end of study period at 3 years
Persistence definition: time from the moment of delivery of the first product, until the estimated time of completion of the last product delivered. This definition has been previously used in this field. A difference of 15% between active and control groups will be considered as clinically meaningful, denoting success of the intervention
4 secondary outcomes
Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group
Time frame: From entry to the end of second year of study period
Comparing the proportion of subjects who maintain therapeutic persistence after completing 1 years of Immunotherapy treatment in the active group vs control group
Time frame: From entry to the end of first year of study period
Comparing the therapeutic self-reported implementation between persistent subjects after completing 3 years of Immunotherapy in the active group vs. the control group
Time frame: From entry to the end of study period at 3 years
Comparing AIT discontinuation reasons in non-persistent patients (ie, withdrawing the treatment), after 3 years of study will be collected
Time frame: From entry to the end of study period at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Adherence-booster App and Inactive Adherence-booster App in people with Allergic Rhinitis, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Rodríguez del Río, MD PhD (+34915035900, prrio@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups (time frame: From entry to the end of study period at 3 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 23 Mar 2026.