Acute Respiratory Tract InfectionsAIRE-PilotNCT07786103
Pilot Intervention to Prevent Complications of Acute Respiratory Infections in Primary Care
A study testing AIRE Comprehensive Respiratory Self-Care Intervention in people with Acute Respiratory Tract Infections, run by University of Chile at 1 site in Chile.
Trial summary
Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Acute Respiratory Tract Infections
- What is being tested?
- AIRE Comprehensive Respiratory Self-Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 9 Sep 2026to 30 Oct 2026
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of any sex aged 60 to 80 years.
- Clinical diagnosis of an ambulatory influenza-like illness, defined as acute-onset cough with fever or a feeling of fever, plus at least one of the following symptoms: muscle aches, sore throat, or headache. Laboratory confirmation of the causative pathogen is not required.
- Five days or less since the onset of the first symptom.
- Presence of at least one of the following chronic conditions or risk factors: hypertension, dyslipidemia, diabetes mellitus, obesity defined as a body mass index of 30 kg/m² or higher, chronic kidney disease, or current smoking.
- Regular access to and use of WhatsApp.
Who cannot join
- Need for antibiotic treatment at the initial visit because of an evident or suspected bacterial infection.
- Cognitive impairment that prevents understanding of the study or intervention.
- Cancer under active treatment.
- Physical limitations that prevent performance of the breathing exercises.
- Hospitalization for any cause within the previous 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
CESFAM Dr. Agustín Cruz Melo
Santiago, Santiago Metropolitan, 8320000
Paulina Pino, PhD, 56 961711476, ppino@uchile.cl
About this study
Official title: Pilot Randomized Controlled Trial of the AIRE Comprehensive Respiratory Self-Care Intervention for Preventing Complications of Acute Respiratory Infections in Older Adults in Primary Care
Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Clear guidance about safe activity, breathing exercises, symptom monitoring, and when to seek further care may support recovery.
The goal of this pilot clinical trial is to assess whether the AIRE respiratory self-care intervention and the planned study procedures can be carried out successfully in adults aged 60 to 80 years who receive care for an acute respiratory infection in a primary care center. The pilot will inform the procedures for a larger randomized clinical trial designed to evaluate whether AIRE can prevent complications.
Read more
The main questions this pilot study aims to answer are:
- Can eligible participants be successfully recruited and enrolled?
- Can participants complete the 14-day follow-up and daily self-report diary?
- Can the AIRE intervention be delivered as planned?
- Can participants assigned to AIRE follow the respiratory self-care recommendations and breathing exercises?
Researchers will also explore whether participants who receive AIRE experience fewer respiratory complications within 14 days than participants who receive usual care. The pilot study is not designed to provide a definitive test of the clinical effectiveness of AIRE.
Participants will be randomly assigned to one of two groups. Participants in the AIRE group will receive usual care plus a respiratory self-care session. The session will include guidance about hydration, safe daily activity, avoidance of prolonged bed rest, warning signs, and simple breathing exercises. Participants will also receive supporting educational material. Participants in the control group will receive usual care without the AIRE intervention.
Participants in both groups will:
- Receive telephone follow-up during the 14 days after enrollment
- Record their symptoms, daily activities, and use of health services in a self-report diary
- Report any new medical visits, hospital admissions, or respiratory complications
The respiratory complications assessed will include sinusitis, bronchitis, pneumonia, and worsening of a long-term health condition. The findings will help researchers identify changes needed before conducting the larger clinical trial.
- Conditions
- Acute Respiratory Tract Infections
- Being tested
- AIRE Comprehensive Respiratory Self-Care Intervention
- Keywords
- Acute respiratory tract infections, Respiratory self-care, Older adults, Breathing exercises, Prevention of complications, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRE Comprehensive Respiratory Self-Care InterventionBehavioural
AIRE is a multicomponent respiratory self-care intervention delivered individually by a trained respiratory physical therapist. Participants receive a structured education session lasting approximately 10 minutes. The session covers hydration, warning signs, safe daily activity, and recommendations to avoid prolonged bed rest during recovery. Participants are taught breathing control followed by slow exhalation through pursed lips. Each breathing exercise session lasts approximately 5 to 10 minutes and is performed twice daily for 5 to 10 consecutive days, according to symptoms and tolerance. Participants are advised to stop the exercises if they experience dizziness, marked shortness of breath, chest pain, or worsening symptoms. Printed or audiovisual materials reinforce the recommendations and exercise instructions.
| Study group | Role | What they receive |
|---|---|---|
| AIRE Comprehensive Respiratory Self-Care Intervention | Experimental | Participants assigned to this arm will receive the AIRE intervention in addition to usual care for acute respiratory infections. The intervention includes respiratory self-care education, guidance to support safe recovery at home, and breathing exercise instruction. Participants will complete the same follow-up and outcome assessments as the control group. Receives: Behavioral: AIRE Comprehensive Respiratory Self-Care Intervention |
| Usual care | No intervention | Participants assigned to this arm will receive usual care for acute respiratory infections according to standard practice at the primary care center, without the AIRE self-care education or breathing exercise instruction. They will undergo the same study follow-up and outcome assessments as participants in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
The proportion of eligible individuals who provide informed consent and are enrolled in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the total number of eligible individuals invited to participate, multiplied by 100. The number of individuals screened, eligible, invited, and enrolled will be recorded. Reasons for exclusion, refusal, or non-enrollment will also be documented and summarized by category.
Measured: Baseline
Completion of 14-Day Follow-Up
The proportion of enrolled participants who complete the final study assessment on day 14. A participant will be considered to have completed follow-up if information on symptoms, healthcare use, and possible respiratory complications is available through the day 14 telephone assessment or clinical record review. The measure will be reported as the number of participants who complete follow-up divided by the total number enrolled, multiplied by 100.
Measured: From enrollment to 14 days after enrollment
Completion of the Daily Self-Report Diary
The proportion of expected daily self-report diary entries completed by participants during the 14-day follow-up period. The diary records symptoms, daily activity, ability to perform usual activities, healthcare use, and, for participants assigned to AIRE, performance of breathing exercises. Completion will be calculated as the number of diary entries submitted divided by the total number of expected entries, multiplied by 100.
Measured: Daily, from enrollment to 14 days after enrollment
Secondary outcomes (4)
Adherence to AIRE Breathing Exercises
The proportion of prescribed breathing exercise sessions completed by participants assigned to the AIRE intervention. Participants are instructed to perform two breathing exercise sessions per day for 5 to 10 days, according to symptoms and tolerance. Adherence will be calculated as the number of sessions reported as completed divided by the total number of sessions prescribed to each participant, multiplied by 100. Participants completing at least 80% of their prescribed sessions will also be classified as adherent. Daily adherence will be obtained from the self-report diary.
Measured: Daily, from enrollment through day 10 after enrollment
Incidence of Respiratory Complications Within 14 Days
The proportion of participants who develop at least one predefined respiratory or clinical complication during follow-up. The composite outcome includes sinusitis, bronchitis, pneumonia, or worsening of a pre-existing chronic health condition. Possible complications will be identified through telephone follow-up, self-report diaries, healthcare visits, and clinical record review using predefined diagnostic criteria.
Measured: From enrollment to 14 days after enrollment
Successful Completion of Scheduled Telephone Contacts
The proportion of the six scheduled telephone follow-up contacts completed for each participant. Telephone contacts are scheduled on days 3, 5, 7, 10, 12, and 14 after enrollment. Completion will be calculated as the number of completed calls divided by six, multiplied by 100. The duration of each call, unsuccessful contact attempts, and reasons for missed calls will also be documented.
Measured: From enrollment to 14 days after enrollment
Successful Delivery of the AIRE Intervention
The proportion of participants assigned to the AIRE intervention who receive all planned components of the initial intervention session. Complete delivery will require respiratory self-care education, guidance on hydration and warning signs, recommendations for safe daily activity and avoidance of prolonged bed rest, breathing exercise instruction, and provision of supporting educational material. Completion will be documented using the structured AIRE intervention checklist and calculated as the number of participants who receive all planned components divided by the total number assigned to the AIRE arm, multiplied by 100.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start9 Sep 2026
- Primary completion20 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786103
- Sponsor's protocol ID
- AIRE422026
- Acronym
- AIRE-Pilot
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team intends to consider sharing de-identified individual participant data after completion of the pilot study and the subsequent full-scale randomized controlled trial. However, the final data-sharing plan has not yet been established. The decision will depend on participant consent, ethics committee requirements, institutional policies of the Universidad de Chile, and the availability of appropriate procedures to ensure anonymization, confidentiality, and responsible data access.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of the AIRE Comprehensive Respiratory Self-Care Intervention for Preventing Complications of Acute Respiratory Infections in Older Adults in Primary Care
- ClinicalTrials.gov ID
- NCT07786103
- Acronym / sponsor ID
- AIRE-Pilot / AIRE422026
- Conditions
- Acute Respiratory Tract Infections
- Keywords
- Acute respiratory tract infections, Respiratory self-care, Older adults, Breathing exercises, Prevention of complications, Pilot study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Aug 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.
Acute respiratory infections are common reasons for seeking primary care. Most people recover at home, but some older adults may develop respiratory complications or worsening of long-term health conditions. Clear guidance about safe activity, breathing exercises, symptom monitoring, and when to seek further care may support recovery.
The goal of this pilot clinical trial is to assess whether the AIRE respiratory self-care intervention and the planned study procedures can be carried out successfully in adults aged 60 to 80 years who receive care for an acute respiratory infection in a primary care center. The pilot will inform the procedures for a larger randomized clinical trial designed to evaluate whether AIRE can prevent complications.
The main questions this pilot study aims to answer are:
- Can eligible participants be successfully recruited and enrolled?
- Can participants complete the 14-day follow-up and daily self-report diary?
- Can the AIRE intervention be delivered as planned?
- Can participants assigned to AIRE follow the respiratory self-care recommendations and breathing exercises?
Researchers will also explore whether participants who receive AIRE experience fewer respiratory complications within 14 days than participants who receive usual care. The pilot study is not designed to provide a definitive test of the clinical effectiveness of AIRE.
Participants will be randomly assigned to one of two groups. Participants in the AIRE group will receive usual care plus a respiratory self-care session. The session will include guidance about hydration, safe daily activity, avoidance of prolonged bed rest, warning signs, and simple breathing exercises. Participants will also receive supporting educational material. Participants in the control group will receive usual care without the AIRE intervention.
Participants in both groups will:
- Receive telephone follow-up during the 14 days after enrollment
- Record their symptoms, daily activities, and use of health services in a self-report diary
- Report any new medical visits, hospital admissions, or respiratory complications
The respiratory complications assessed will include sinusitis, bronchitis, pneumonia, and worsening of a long-term health condition. The findings will help researchers identify changes needed before conducting the larger clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIRE Comprehensive Respiratory Self-Care Intervention | Experimental | Behavioral: AIRE Comprehensive Respiratory Self-Care InterventionParticipants assigned to this arm will receive the AIRE intervention in addition to usual care for acute respiratory infections. The intervention includes respiratory self-care education, guidance to support safe recovery at home, and breathing exercise instruction. Participants will complete the same follow-up and outcome assessments as the control group. |
| Usual care | No intervention | –Participants assigned to this arm will receive usual care for acute respiratory infections according to standard practice at the primary care center, without the AIRE self-care education or breathing exercise instruction. They will undergo the same study follow-up and outcome assessments as participants in the experimental group. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults of any sex aged 60 to 80 years.
- Clinical diagnosis of an ambulatory influenza-like illness, defined as acute-onset cough with fever or a feeling of fever, plus at least one of the following symptoms: muscle aches, sore throat, or headache. Laboratory confirmation of the causative pathogen is not required.
- Five days or less since the onset of the first symptom.
- Presence of at least one of the following chronic conditions or risk factors: hypertension, dyslipidemia, diabetes mellitus, obesity defined as a body mass index of 30 kg/m² or higher, chronic kidney disease, or current smoking.
- Regular access to and use of WhatsApp.
Key exclusion criteria (5 listed)
- Need for antibiotic treatment at the initial visit because of an evident or suspected bacterial infection.
- Cognitive impairment that prevents understanding of the study or intervention.
- Cancer under active treatment.
- Physical limitations that prevent performance of the breathing exercises.
- Hospitalization for any cause within the previous 6 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 |
|---|---|---|
| AIRE Comprehensive Respiratory Self-Care InterventionAIRE is a multicomponent respiratory self-care intervention delivered individually by a trained respiratory physical therapist. Participants receive a structured education session lasting approximately 10 minutes. The session covers hydration, warning signs, safe daily activity, and recommendations to avoid prolonged bed rest during recovery. Participants are taught breathing control followed by slow exhalation through pursed lips. Each breathing exercise session lasts approximately 5 to 10 minutes and is performed twice daily for 5 to 10 consecutive days, according to symptoms and tolerance. Participants are advised to stop the exercises if they experience dizziness, marked shortness of breath, chest pain, or worsening symptoms. Printed or audiovisual materials reinforce the recommendations and exercise instructions. | Behavioural | AIRE Comprehensive Respiratory Self-Care Intervention |
Primary outcome
Participant Recruitment Rate
Time frame: Baseline
The proportion of eligible individuals who provide informed consent and are enrolled in the study. The recruitment rate will be calculated as the number of participants enrolled divided by the total number of eligible individuals invited to participate, multiplied by 100. The number of individuals screened, eligible, invited, and enrolled will be recorded. Reasons for exclusion, refusal, or non-enrollment will also be documented and summarized by category.
Completion of 14-Day Follow-Up
Time frame: From enrollment to 14 days after enrollment
The proportion of enrolled participants who complete the final study assessment on day 14. A participant will be considered to have completed follow-up if information on symptoms, healthcare use, and possible respiratory complications is available through the day 14 telephone assessment or clinical record review. The measure will be reported as the number of participants who complete follow-up divided by the total number enrolled, multiplied by 100.
Completion of the Daily Self-Report Diary
Time frame: Daily, from enrollment to 14 days after enrollment
The proportion of expected daily self-report diary entries completed by participants during the 14-day follow-up period. The diary records symptoms, daily activity, ability to perform usual activities, healthcare use, and, for participants assigned to AIRE, performance of breathing exercises. Completion will be calculated as the number of diary entries submitted divided by the total number of expected entries, multiplied by 100.
4 secondary outcomes
Adherence to AIRE Breathing Exercises
Time frame: Daily, from enrollment through day 10 after enrollment
Incidence of Respiratory Complications Within 14 Days
Time frame: From enrollment to 14 days after enrollment
Successful Completion of Scheduled Telephone Contacts
Time frame: From enrollment to 14 days after enrollment
Successful Delivery of the AIRE Intervention
Time frame: Day 1
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 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. The study team intends to consider sharing de-identified individual participant data after completion of the pilot study and the subsequent full-scale randomized controlled trial. However, the final data-sharing plan has not yet been established. The decision will depend on participant consent, ethics committee requirements, institutional policies of the Universidad de Chile, and the availability of appropriate procedures to ensure anonymization, confidentiality, and responsible data access.
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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 AIRE Comprehensive Respiratory Self-Care Intervention in people with Acute Respiratory Tract Infections, run by University of Chile at 1 site in Chile.
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 22 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 Chile. 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 Manuel A Rain, MSc (56 976345940, manuel.rain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: Baseline). 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?
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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.