Asthma (Diagnosis)OSADANCT07160868
Obstructive Sleep Apnoea and Difficult Asthma (OSADA)
A study testing Continuous positive airway pressure (CPAP) in people with Asthma (Diagnosis) and OSA - Obstructive Sleep Apnea, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma (Diagnosis), OSA - Obstructive Sleep Apnea, CPAP Treatment
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2025to 22 May 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a clinical diagnosis of asthma with supportive objective diagnostics including but not limited to, variable airflow obstruction, bronchial-hyper responsiveness and demonstrable eosinophilic inflammation via fractional exhaled nitric oxide or peripheral eosinophilia
- Patients receiving step 4 or step 5 of 'The Global Initiative for Asthma' (GINA) treatment guidelines will be selected
- Between the ages of 18 to 90 years of age
Who cannot join
- Patients with previous sleep study investigations
- Excessive daytime sleepiness; ESS >17
- Previous diagnosis of a sleep disorder
- Resting hypoxaemia or need for long-term oxygen therapy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
St. James's Hospital
Dublin, Dublin
Laura Piggott, 0876801786, laurampiggott@gmail.com
About this study
Official title: Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma.
Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group).
Read more
The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization.
This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.
Read the detailed description
Obstructive sleep apnoea (OSA) and asthma are two of the most common respiratory disorders worldwide, with asthma estimated to affect 300 million, and OSA in the region of 1 billion people. As a result, these two disorders frequently coexist in the same person. Whilst most people with asthma achieve successful control of their condition with straightforward inhaler therapy, approximately 20% have Difficult Asthma, characterised by persistent symptoms despite high dose inhaler usage. These patients experience a significant degree of morbidity due to their asthma, with increased healthcare utilisation, limitations in activities of daily living, and an increased need for systemic corticosteroids compared to those with milder asthma. Although novel biologic therapies have improved outcomes for some of these patients, there remain significant unmet needs in the care of many.
OSA is consistently listed as an important comorbidity in Difficult Asthma, with the suggestion being that it may have a significant detrimental impact on the ability to successfully achieve asthma control. However, there is a lack of systematic assessments of the relationship between the presence and severity of OSA on asthma symptoms in Difficult Asthma cohorts, and very little is known about the effect that treating OSA has in terms of airflow variability and asthma control.
The investigators aim to conduct an open-label randomized controlled trial to study patients attending Difficult Asthma clinics. Participants will undergo home sleep studies to investigate for an underlying concurrent diagnosis of sleep apnoea. The investigators will examine baseline and longitudinal relationships between OSA and asthma exacerbations, variability of airflow (via home peak flow monitoring), patient-reported asthma control, lung function, and markers of airway inflammation over a 3-month period, allowing a comparison of patients with OSA and those without.
Patients with confirmed OSA, as defined as an apnoea-hypopnea index of ≥10 events/hour will be randomized into treatment [continuous positive airway pressure (CPAP) therapy] and no treatment groups. Again, airflow variability, exacerbation frequency, asthma control, lung function and airway inflammation will be compared between OSA patients who receive CPAP therapy and those who do not.
- Being tested
- Continuous positive airway pressure (CPAP)
- Medical subject headings
- Asthma, Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea
| Study group | Role | What they receive |
|---|---|---|
| Asthma - no sleep apnoea | No intervention | This the group of asthma patients without sleep apnoea |
| Asthma - sleep apnoea, no treatment | No intervention | This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the no treatment arm |
| Asthma - sleep apnoea, treatment | Experimental | This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the treatment arm. They will receive CPAP therapy as treatment for sleep apnoea, while monitoring their asthma control measures and airflow variability. Receives: Device: Continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airflow variability measured by home electronic peak flow monitoring
Airflow variability will be assessed using peak expiratory flow rate (PEFR) measured with electronic home peak flow meters. Variability will be calculated using the daily amplitude percent mean (DAPM) method. Participants will be asked to record PEFR twice daily (early morning and late afternoon) over the defined period to provide adequate data points. For each day, variability will be calculated using the DAPM formula, and the average daily variability across the collection period will then be derived.
Measured: 3-4 months
Secondary outcomes (4)
Change in asthma control
As measured by;
-Asthma Control test (ACT) scoring
Measured: 3-4 months
Change in asthma control
As measured by;
-Asthma quality of life questionnaire (AQLQ) score
Measured: 3-4 months
Change in asthma control
Exacerbation frequency
Measured: 3-4 months
Change in asthma control
Change in airway inflammation markers (FeNO)
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025
- Primary completion22 May 2026 (estimated)
- Study completion22 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Tallaght University Hospital
- Responsible party
- Principal investigator, Laura Piggott, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160868
- Sponsor's protocol ID
- 4211
- Acronym
- OSADA
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2025
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma
- ClinicalTrials.gov ID
- NCT07160868
- Acronym / sponsor ID
- OSADA / 4211
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Tallaght University Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 May 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma.
Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group).
The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization.
This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.
Detailed description
Obstructive sleep apnoea (OSA) and asthma are two of the most common respiratory disorders worldwide, with asthma estimated to affect 300 million, and OSA in the region of 1 billion people. As a result, these two disorders frequently coexist in the same person. Whilst most people with asthma achieve successful control of their condition with straightforward inhaler therapy, approximately 20% have Difficult Asthma, characterised by persistent symptoms despite high dose inhaler usage. These patients experience a significant degree of morbidity due to their asthma, with increased healthcare utilisation, limitations in activities of daily living, and an increased need for systemic corticosteroids compared to those with milder asthma. Although novel biologic therapies have improved outcomes for some of these patients, there remain significant unmet needs in the care of many.
OSA is consistently listed as an important comorbidity in Difficult Asthma, with the suggestion being that it may have a significant detrimental impact on the ability to successfully achieve asthma control. However, there is a lack of systematic assessments of the relationship between the presence and severity of OSA on asthma symptoms in Difficult Asthma cohorts, and very little is known about the effect that treating OSA has in terms of airflow variability and asthma control.
The investigators aim to conduct an open-label randomized controlled trial to study patients attending Difficult Asthma clinics. Participants will undergo home sleep studies to investigate for an underlying concurrent diagnosis of sleep apnoea. The investigators will examine baseline and longitudinal relationships between OSA and asthma exacerbations, variability of airflow (via home peak flow monitoring), patient-reported asthma control, lung function, and markers of airway inflammation over a 3-month period, allowing a comparison of patients with OSA and those without.
Patients with confirmed OSA, as defined as an apnoea-hypopnea index of ≥10 events/hour will be randomized into treatment [continuous positive airway pressure (CPAP) therapy] and no treatment groups. Again, airflow variability, exacerbation frequency, asthma control, lung function and airway inflammation will be compared between OSA patients who receive CPAP therapy and those who do not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma - no sleep apnoea | No intervention | –This the group of asthma patients without sleep apnoea |
| Asthma - sleep apnoea, no treatment | No intervention | –This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the no treatment arm |
| Asthma - sleep apnoea, treatment | Experimental | Device: Continuous positive airway pressure (CPAP)This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the treatment arm. They will receive CPAP therapy as treatment for sleep apnoea, while monitoring their asthma control measures and airflow variability. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have a clinical diagnosis of asthma with supportive objective diagnostics including but not limited to, variable airflow obstruction, bronchial-hyper responsiveness and demonstrable eosinophilic inflammation via fractional exhaled nitric oxide or peripheral eosinophilia
- Patients receiving step 4 or step 5 of 'The Global Initiative for Asthma' (GINA) treatment guidelines will be selected
- Between the ages of 18 to 90 years of age
Key exclusion criteria (5 listed)
- Patients with previous sleep study investigations
- Excessive daytime sleepiness; ESS >17
- Previous diagnosis of a sleep disorder
- Resting hypoxaemia or need for long-term oxygen therapy
- Inability to provide informed consent
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 |
|---|---|---|
| Continuous positive airway pressure (CPAP)Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea | Device | Asthma - sleep apnoea, treatment |
Primary outcome
Change in airflow variability measured by home electronic peak flow monitoring
Time frame: 3-4 months
Airflow variability will be assessed using peak expiratory flow rate (PEFR) measured with electronic home peak flow meters. Variability will be calculated using the daily amplitude percent mean (DAPM) method. Participants will be asked to record PEFR twice daily (early morning and late afternoon) over the defined period to provide adequate data points. For each day, variability will be calculated using the DAPM formula, and the average daily variability across the collection period will then be derived.
4 secondary outcomes
Change in asthma control
Time frame: 3-4 months
Change in asthma control
Time frame: 3-4 months
Change in asthma control
Time frame: 3-4 months
Change in asthma control
Time frame: 3-4 months
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 26 May 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 Continuous positive airway pressure (CPAP) in people with Asthma (Diagnosis) and OSA - Obstructive Sleep Apnea, run by St. James's Hospital, Ireland at 1 site in Ireland.
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 3 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 26 May 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 Ireland. 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 Laura Piggott, BM BS BSc MSc (+353876801786, laurampiggott@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in airflow variability measured by home electronic peak flow monitoring (time frame: 3-4 months). 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 26 May 2026.