AsthmaRESPiraIANCT07635537
Structured Nursing Intervention for Adults With Poorly Controlled Asthma: A Pilot Study
A study testing RESPiraIA-Asma in people with Asthma and Medication Adherence, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Medication Adherence, Self-management
- What is being tested?
- RESPiraIA-Asma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Sep 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of mild or moderate persistent, non-severe asthma.
- Poorly controlled asthma, defined as an Asthma Control Test (ACT) score below 20.
- Active inhaled maintenance therapy with inhaled corticosteroids (ICS), alone or combined with a long-acting beta-agonist (LABA).
- Age 18 years or older.
- Active follow-up in the Pulmonology outpatient clinic of Hospital Clínico San Carlos.
- Sufficient cognitive capacity to participate and complete the questionnaires.
- Access to a means of communication (in-person, telephone, digital, or mixed).
- Signed informed consent.
Who cannot join
- Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COPD), bronchiectasis, pulmonary fibrosis, chronic pulmonary thromboembolism, or home oxygen therapy).
- Acute asthma exacerbation within the 4 weeks before inclusion.
- Participation in another clinical trial within the previous 12 months.
- Cognitive impairment or language barriers preventing completion of the questionnaires.
- Conditions limiting continuity of follow-up over the 12 months.
- Mild comorbidities such as allergic rhinitis or mild sleep apnea are not exclusion criteria.
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
Centro de Especialidades Modesto Lafuente (Hospital Clínico San Carlos)
Madrid
About this study
Official title: Design and Development of RESPiraIA-Asthma: A Structured Nursing Intervention for the Follow-up of Adults With Poorly Controlled Asthma. A Pilot Study
Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. RESPiraIA-Asma is a 12-month structured nursing intervention designed to address these gaps in adults with poorly controlled, non-severe asthma.
This is a quasi-experimental, single-group, before-and-after pilot study. Each participant is followed across six visits over one year, at baseline and at months 1, 3, 6, 9, and 12. The intervention combines therapeutic education, inhaler technique training, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized nursing care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.
Read more
A central principle of the model is digital equity: the same standard of care is offered through three equivalent access routes (digital, mixed, or in-person), chosen according to each participant's digital skills, resources, and preferences, so that technology never becomes a barrier to access.
The study evaluates whether the model is feasible to deliver in routine clinical practice, measured through participant retention, data completeness, and acceptability, and it looks for preliminary signals of its effect on asthma control, treatment adherence, lung function, and biopsychosocial well-being. As an exploratory pilot, it is not designed to confirm efficacy; its purpose is to inform the design of a larger future trial.
Read the detailed description
RESPiraIA-Asma is the first pilot application of the RESPiraIA model, a structured nursing intervention built on three operational cores. The administrative core covers governance and digital equity through three equivalent access routes (digital, mixed, and in-person). The clinical core triangulates asthma control and treatment adherence using three validated instruments: the Asthma Control Test (ACT) for clinical control, the Test of Adherence to Inhalers (TAI) for self-reported adherence, and the Medication Possession Ratio (MPR) for objective adherence from pharmacy dispensing, with automatic calculation of the discrepancy between self-reported and objective adherence as an active clinical indicator. The nursing core delivers a standardized care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.
The study sits within the development and feasibility phases of the Medical Research Council (MRC) framework for complex interventions. It is not a confirmatory efficacy trial; the clinical outcomes are evaluated as preliminary signals intended to inform the design of a future multicentre confirmatory trial. Pre-pilot functional verification of the data capture system, REDCap (Research Electronic Data Capture), was carried out using systematic synthetic profiles before the start of recruitment.
- Conditions
- Asthma, Medication Adherence, Self-management
- Being tested
- RESPiraIA-Asma
- Keywords
- Asthma, Nursing Diagnosis, Treatment Adherence and Compliance, Nursing Care, Digital Divide, Digital Technology, Artificial Intelligence, Structured nursing intervention, NANDA-I, NIC, NOC
- Medical subject headings
- Asthma, Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPiraIA-AsmaBehavioural
Structured nursing intervention of 12 months organized in three operational cores (administrative, clinical, and nursing) and delivered across six visits. It combines therapeutic education, inhaler technique training with the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) checklist, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized care plan based on the NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC) taxonomies, activated by objective clinical thresholds. Treatment adherence is monitored through the triangulation of the Asthma Control Test (ACT), the Test of Adherence to Inhalers (TAI), and the Medication Possession Ratio (MPR). Follow-up and the deterministic care logic run in REDCap (Research Electronic Data Capture).
| Study group | Role | What they receive |
|---|---|---|
| RESPiraIA-Asma structured nursing intervention | Experimental | Single experimental arm: all enrolled participants receive the RESPiraIA-Asma intervention, with no control group, and comparisons are within-subject (baseline versus month 12). Follow-up lasts 12 months across six visits (baseline and months 1, 3, 6, 9, and 12). Each participant is assigned to one of three equivalent access modalities (digital, mixed, or in-person) according to digital competence, internet access, available devices, and preference. The clinical content is identical across modalities, and participants may switch modality during follow-up if their circumstances change. Receives: Behavioral: RESPiraIA-Asma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma control measured by the Asthma Control Test (ACT)
Asthma control assessed with the Asthma Control Test (ACT), a 5-item questionnaire scored from 5 to 25. The main analysis is the within-subject change from baseline to month 12, with a minimal clinically important difference of at least 3 points. The ACT is also the continuous variable used for the sample size calculation.
Measured: Baseline, month 6, month 9, and month 12
Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)
Objective adherence to inhaled maintenance therapy, calculated from pharmacy dispensing records as medication dispensed divided by medication prescribed, expressed as a percentage. A value of at least 80% is considered adequate. In participants with recent treatment initiation (less than 6 months), the ratio is not computable at baseline and adherence is assessed through the Test of Adherence to Inhalers (TAI) and inhaler technique.
Measured: Baseline, month 1, month 6, month 9, and month 12
Change in self-reported treatment adherence measured by the Test of Adherence to Inhalers (TAI)
Self-reported adherence assessed with the Test of Adherence to Inhalers (TAI), a 12-item questionnaire; a score of at least 50 indicates good adherence. It is first administered at month 1 because it evaluates adherence behaviour over a prior treatment period, not applicable at baseline.
Measured: Month 1, month 6, month 9, and month 12
Secondary outcomes (6)
Change in lung function (forced expiratory volume in the first second, FEV1)
Lung function measured by spirometry and expressed as the forced expiratory volume in the first second (FEV1) as a percentage of the predicted value.
Measured: Baseline, month 6, and month 12
Change in inhaler technique
Inhaler technique assessed by direct observation using the 8-step checklist of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), recorded as the number of correctly performed steps out of 8.
Measured: Baseline, month 3, month 6, and month 12
Change in emotional health (Hospital Anxiety and Depression Scale, HADS)
Emotional health assessed with the Hospital Anxiety and Depression Scale (HADS), with anxiety and depression subscales each scored from 0 to 21. Change analysed from month 1 to month 9.
Measured: Month 1 and month 9
Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)
Adherence to the Mediterranean diet assessed with the 14-item PREDIMED questionnaire; a score of at least 9 indicates good dietary adherence. Change analysed from month 1 to month 9.
Measured: Month 1 and month 9
Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)
Health-related quality of life assessed with the EuroQol-5D-5L (EQ-5D-5L), covering five health dimensions with five severity levels each, plus a visual analogue scale.
Measured: Baseline and month 12
Change in asthma knowledge (RESPiraIA-Knowledge questionnaire)
Functional knowledge about asthma and its management assessed with the RESPiraIA-Knowledge questionnaire, a 12-item instrument developed for this study, content-validated by an expert panel (scale-level content validity index, average, of 0.97).
Measured: Baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same structured nursing intervention, RESPiraIA-Asma, in a single-group, before-and-after design with no control group; comparisons are within-subject, from baseline to month 12. The intervention is delivered through three equivalent access modalities (digital, mixed, or in-person), assigned according to digital competence, internet access, available devices, and patient preference. These modalities are access channels only: the clinical content, including instruments, activation thresholds, and assessment time points, is identical across all of them, so they do not constitute separate study arms. Participants may change modality during follow-up if their circumstances change, and any change is recorded as a follow-up variable.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad Nacional de Educación a Distancia, Instituto de Investigación Sanitaria San Carlos (IdISSC)
- Responsible party
- Principal investigator, Elena Fariñas Álvarez, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635537
- Sponsor's protocol ID
- 26/114-E
- Acronym
- RESPiraIA
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available, including the clinical, adherence, and biopsychosocial outcome variables collected during the study (asthma control, treatment adherence, lung function, inhaler technique, emotional health, dietary habits, quality of life, and asthma knowledge). Data will be shared upon reasonable request to the corresponding author, after the end of the follow-up period, in accordance with the FAIR principles and EU data protection regulation (GDPR).
Publications
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
PubMed 26230150Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
PubMed 38564982
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of RESPiraIA-Asthma: A Structured Nursing Intervention for the Follow-up of Adults With Poorly Controlled Asthma. A Pilot Study
- ClinicalTrials.gov ID
- NCT07635537
- Acronym / sponsor ID
- RESPiraIA / 26/114-E
- Conditions
- Asthma, Medication Adherence, Self-management
- Keywords
- Asthma, Nursing Diagnosis, Treatment Adherence and Compliance, Nursing Care, Digital Divide, Digital Technology, Artificial Intelligence, Structured nursing intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Universidad Nacional de Educación a Distancia, Instituto de Investigación Sanitaria San Carlos (IdISSC)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 9 Jun 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.
Asthma affects a large number of adults, and many of them do not achieve good control of their symptoms. Poor inhaler technique, irregular medication use, and the lack of structured nursing follow-up are among the main reasons. RESPiraIA-Asma is a 12-month structured nursing intervention designed to address these gaps in adults with poorly controlled, non-severe asthma.
This is a quasi-experimental, single-group, before-and-after pilot study. Each participant is followed across six visits over one year, at baseline and at months 1, 3, 6, 9, and 12. The intervention combines therapeutic education, inhaler technique training, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized nursing care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.
A central principle of the model is digital equity: the same standard of care is offered through three equivalent access routes (digital, mixed, or in-person), chosen according to each participant's digital skills, resources, and preferences, so that technology never becomes a barrier to access.
The study evaluates whether the model is feasible to deliver in routine clinical practice, measured through participant retention, data completeness, and acceptability, and it looks for preliminary signals of its effect on asthma control, treatment adherence, lung function, and biopsychosocial well-being. As an exploratory pilot, it is not designed to confirm efficacy; its purpose is to inform the design of a larger future trial.
Detailed description
RESPiraIA-Asma is the first pilot application of the RESPiraIA model, a structured nursing intervention built on three operational cores. The administrative core covers governance and digital equity through three equivalent access routes (digital, mixed, and in-person). The clinical core triangulates asthma control and treatment adherence using three validated instruments: the Asthma Control Test (ACT) for clinical control, the Test of Adherence to Inhalers (TAI) for self-reported adherence, and the Medication Possession Ratio (MPR) for objective adherence from pharmacy dispensing, with automatic calculation of the discrepancy between self-reported and objective adherence as an active clinical indicator. The nursing core delivers a standardized care plan based on internationally recognized nursing taxonomies for diagnoses, interventions, and outcomes: NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC), activated by objective clinical thresholds.
The study sits within the development and feasibility phases of the Medical Research Council (MRC) framework for complex interventions. It is not a confirmatory efficacy trial; the clinical outcomes are evaluated as preliminary signals intended to inform the design of a future multicentre confirmatory trial. Pre-pilot functional verification of the data capture system, REDCap (Research Electronic Data Capture), was carried out using systematic synthetic profiles before the start of recruitment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same structured nursing intervention, RESPiraIA-Asma, in a single-group, before-and-after design with no control group; comparisons are within-subject, from baseline to month 12. The intervention is delivered through three equivalent access modalities (digital, mixed, or in-person), assigned according to digital competence, internet access, available devices, and patient preference. These modalities are access channels only: the clinical content, including instruments, activation thresholds, and assessment time points, is identical across all of them, so they do not constitute separate study arms. Participants may change modality during follow-up if their circumstances change, and any change is recorded as a follow-up variable.
| Arm | Type | Receives |
|---|---|---|
| RESPiraIA-Asma structured nursing intervention | Experimental | Behavioral: RESPiraIA-AsmaSingle experimental arm: all enrolled participants receive the RESPiraIA-Asma intervention, with no control group, and comparisons are within-subject (baseline versus month 12). Follow-up lasts 12 months across six visits (baseline and months 1, 3, 6, 9, and 12). Each participant is assigned to one of three equivalent access modalities (digital, mixed, or in-person) according to digital competence, internet access, available devices, and preference. The clinical content is identical across modalities, and participants may switch modality during follow-up if their circumstances change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of mild or moderate persistent, non-severe asthma.
- Poorly controlled asthma, defined as an Asthma Control Test (ACT) score below 20.
- Active inhaled maintenance therapy with inhaled corticosteroids (ICS), alone or combined with a long-acting beta-agonist (LABA).
- Age 18 years or older.
- Active follow-up in the Pulmonology outpatient clinic of Hospital Clínico San Carlos.
Key exclusion criteria (6 listed)
- Significant respiratory comorbidity (chronic obstructive pulmonary disease ( COPD), bronchiectasis, pulmonary fibrosis, chronic pulmonary thromboembolism, or home oxygen therapy).
- Acute asthma exacerbation within the 4 weeks before inclusion.
- Participation in another clinical trial within the previous 12 months.
- Cognitive impairment or language barriers preventing completion of the questionnaires.
- Conditions limiting continuity of follow-up over the 12 months.
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 |
|---|---|---|
| RESPiraIA-AsmaStructured nursing intervention of 12 months organized in three operational cores (administrative, clinical, and nursing) and delivered across six visits. It combines therapeutic education, inhaler technique training with the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) checklist, home peak-flow self-monitoring, biopsychosocial assessment, and a standardized care plan based on the NANDA International (NANDA-I), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC) taxonomies, activated by objective clinical thresholds. Treatment adherence is monitored through the triangulation of the Asthma Control Test (ACT), the Test of Adherence to Inhalers (TAI), and the Medication Possession Ratio (MPR). Follow-up and the deterministic care logic run in REDCap (Research Electronic Data Capture). | Behavioural | RESPiraIA-Asma structured nursing intervention |
Primary outcome
Change in asthma control measured by the Asthma Control Test (ACT)
Time frame: Baseline, month 6, month 9, and month 12
Asthma control assessed with the Asthma Control Test (ACT), a 5-item questionnaire scored from 5 to 25. The main analysis is the within-subject change from baseline to month 12, with a minimal clinically important difference of at least 3 points. The ACT is also the continuous variable used for the sample size calculation.
Change in objective treatment adherence measured by the Medication Possession Ratio (MPR)
Time frame: Baseline, month 1, month 6, month 9, and month 12
Objective adherence to inhaled maintenance therapy, calculated from pharmacy dispensing records as medication dispensed divided by medication prescribed, expressed as a percentage. A value of at least 80% is considered adequate. In participants with recent treatment initiation (less than 6 months), the ratio is not computable at baseline and adherence is assessed through the Test of Adherence to Inhalers (TAI) and inhaler technique.
Change in self-reported treatment adherence measured by the Test of Adherence to Inhalers (TAI)
Time frame: Month 1, month 6, month 9, and month 12
Self-reported adherence assessed with the Test of Adherence to Inhalers (TAI), a 12-item questionnaire; a score of at least 50 indicates good adherence. It is first administered at month 1 because it evaluates adherence behaviour over a prior treatment period, not applicable at baseline.
6 secondary outcomes
Change in lung function (forced expiratory volume in the first second, FEV1)
Time frame: Baseline, month 6, and month 12
Change in inhaler technique
Time frame: Baseline, month 3, month 6, and month 12
Change in emotional health (Hospital Anxiety and Depression Scale, HADS)
Time frame: Month 1 and month 9
Change in dietary habits (PREDIMED Mediterranean diet adherence questionnaire)
Time frame: Month 1 and month 9
Change in health-related quality of life (EuroQol-5D-5L, EQ-5D-5L)
Time frame: Baseline and month 12
Change in asthma knowledge (RESPiraIA-Knowledge questionnaire)
Time frame: Baseline and month 12
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 18 Sep 2026.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 26230150Plaza V, Fernandez-Rodriguez C, Melero C, Cosio BG, Entrenas LM, de Llano LP, Gutierrez-Pereyra F, Tarragona E, Palomino R, Lopez-Vina A; TAI Study Group. Validation of the 'Test of the Adherence to Inhalers' (TAI) for Asthma and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2016 Apr;29(2):142-52. doi: 10.1089/jamp.2015.1212. Epub 2015 Jul 31.
- Background: PubMed 38564982Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available, including the clinical, adherence, and biopsychosocial outcome variables collected during the study (asthma control, treatment adherence, lung function, inhaler technique, emotional health, dietary habits, quality of life, and asthma knowledge). Data will be shared upon reasonable request to the corresponding author, after the end of the follow-up period, in accordance with the FAIR principles and EU data protection regulation (GDPR).
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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 RESPiraIA-Asma in people with Asthma and Medication Adherence, run by Hospital San Carlos, Madrid 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 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: opening soon, as of the sponsor's last update on 18 Sep 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 Elena Fariñas Álvarez, RN, MSc (34652114649, elena.farinas@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in asthma control measured by the Asthma Control Test (ACT) (time frame: Baseline, month 6, month 9, and month 12). The study lists 3 primary outcomes in all. 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 NCT07635537, which also lists 3 linked publications.
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 18 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.