Pulmonary EmbolismPhase 3AIRENCT04003116
Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)
A Phase 3 study testing Oxygen gas in people with Pulmonary Embolism, run by Ministry of Health, Spain at 7 sites in Spain.
Trial summary
The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Oxygen gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesSpain
- Study dates
- 11 Jul 2019to 25 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
- Disfunction of right ventricle (RV to left ventricle [LV] diameter ratio >1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
- Signed and dated informed consent of the subject.
Who cannot join
- <18 years old.
- Allergy to iodinated contrast.
- Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
- Use of chronic oxygen therapy.
- Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
- Technically inadequate basal echocardiography.
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- Contraindication to anticoagulant therapy.
- Symptoms duration >10 days.
- Haemodynamic instability.
- Participation in other clinical trial for PE treatment during the present clinical trial.
- Inability to use mask or nasal prongs.
- Life expectancy less than 90 days.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Galdakao-Usansolo
Galdakao, Vizcaya
Clínica Universidad de Navarra
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario y Politécnico La Fe
Valencia
Hospital Universitario Araba
Vitoria-Gasteiz, Alava
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
- Conditions
- Pulmonary Embolism
- Being tested
- Oxygen gas
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen gasDrug
Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Supplementary oxygen | Experimental | Supplementary oxygen added to conventional anticoagulant treatment. Receives: Drug: Oxygen gas |
| Standard medical therapy | No intervention | Standard management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal right ventricle function at 48 hours
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
Measured: 48 hours
Secondary outcomes (1)
Modification RV -LV 7 days
Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 7 days after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start11 Jul 2019
- Primary completion24 Apr 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Spain
- Sponsor type
- Other government
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, David Jimenez, Ministry of Health, Spain
- Investigators
- David Jiménez, Study chair, IRYCIS, Alcala de Henares University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003116
- Sponsor's protocol ID
- 2019-000266-37
- Other IDs
- 2019
- Acronym
- AIRE
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2019
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrios D, Duran D, Rodriguez C, Moises J, Retegui A, Lobo JL, Lopez R, Chasco L, Jara-Palomares L, Muriel A, Otero-Candelera R, Ruiz-Artacho P, Monreal M, Bikdeli B, Jimenez D; Air vs Oxygen for Intermediate-Risk Pulmonary Embolism Investigators. Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial. Chest. 2024 Mar;165(3):673-681. doi: 10.1016/j.chest.2023.09.007. Epub 2023 Sep 16.
PubMed 37717936
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With Supplementary Oxygen in Patients With Intermediate-Risk Pulmonary Embolism (PE)
- ClinicalTrials.gov ID
- NCT04003116
- Acronym / sponsor ID
- AIRE / 2019-000266-37
- Conditions
- Pulmonary Embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ministry of Health, SpainOther government
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 1 Jul 2019 (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 primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementary oxygen | Experimental | Drug: Oxygen gasSupplementary oxygen added to conventional anticoagulant treatment. |
| Standard medical therapy | No intervention | –Standard management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
- Disfunction of right ventricle (RV to left ventricle [LV] diameter ratio >1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
- Signed and dated informed consent of the subject.
Key exclusion criteria (12 listed)
- <18 years old.
- Allergy to iodinated contrast.
- Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
- Use of chronic oxygen therapy.
- Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
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 |
|---|---|---|
| Oxygen gasSupplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines. | Drug | Supplementary oxygen |
Primary outcome
Normal right ventricle function at 48 hours
Time frame: 48 hours
Right ventricle (RV) to left ventricle (LV) diameter ratio equal or less than 1.0 measured 48 hours after initiation of therapy in normotensive patients with intermediate-risk pulmonary embolism (PE).
1 secondary outcome
Modification RV -LV 7 days
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Derived from this study: PubMed 37717936Barrios D, Duran D, Rodriguez C, Moises J, Retegui A, Lobo JL, Lopez R, Chasco L, Jara-Palomares L, Muriel A, Otero-Candelera R, Ruiz-Artacho P, Monreal M, Bikdeli B, Jimenez D; Air vs Oxygen for Intermediate-Risk Pulmonary Embolism Investigators. Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial. Chest. 2024 Mar;165(3):673-681. doi: 10.1016/j.chest.2023.09.007. Epub 2023 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Jiménez study chair
IRYCIS, Alcala de Henares University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen gas in people with Pulmonary Embolism, run by Ministry of Health, Spain at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal right ventricle function at 48 hours (time frame: 48 hours). 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 NCT04003116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.