Bronchiolitis Obliterans SyndromeOSCILLOPOUMONNCT01807975
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome
A study testing Forced oscillation in people with Bronchiolitis Obliterans Syndrome, run by Hopital Foch at 1 site in France.
Trial summary
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome
- What is being tested?
- Forced oscillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Sep 2015
- Phase
- Interventional
- 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
- Patients of more than 18 year-old.
- Patients with cardiopulmonary transplant or bilateral lung transplant.
- Clinically stable patients
Who cannot join
- Patients already diagnosed with bronchiolitis obliterans.
- Respiratory infection.
- Acute graft rejection.
- Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
- Iatrogenic pneumopathy.
- Inability to perform Respiratory function test.
Trial locations and contacts
1 site in 1 country.
About this study
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).
- Conditions
- Bronchiolitis Obliterans Syndrome
- Being tested
- Forced oscillation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced oscillationOther
| Study group | Role | What they receive |
|---|---|---|
| post allogreffe patients | Experimental | Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients Receives: Other: Forced oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterans SyndromeStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807975
- Sponsor's protocol ID
- 2010/56
- Acronym
- OSCILLOPOUMON
- Status last verified
- May 2016
- First submitted
- 7 Mar 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome
- ClinicalTrials.gov ID
- NCT01807975
- Acronym / sponsor ID
- OSCILLOPOUMON / 2010/56
- Conditions
- Bronchiolitis Obliterans Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Mar 2013 (estimated)
- 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.
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post allogreffe patients | Experimental | Other: Forced oscillationFunctional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of more than 18 year-old.
- Patients with cardiopulmonary transplant or bilateral lung transplant.
- Clinically stable patients
Key exclusion criteria (6 listed)
- Patients already diagnosed with bronchiolitis obliterans.
- Respiratory infection.
- Acute graft rejection.
- Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
- Iatrogenic pneumopathy.
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 |
|---|---|---|
| Forced oscillation | Other | post allogreffe patients |
Primary outcome
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
Time frame: 2 years
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 28 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced oscillation in people with Bronchiolitis Obliterans Syndrome, run by Hopital Foch at 1 site in France.
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 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: finished, as of the sponsor's last update on 28 Jul 2016. 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 France. 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?
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?
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode). (time frame: 2 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 28 Jul 2016.