Chronic Respiratory FailurePhase 1/2NCT02515786
Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula
A Phase 1/2 study testing oxygen humidification in people with Chronic Respiratory Failure, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
During normal breathing, the upper and lower airways performs the priming of inspired gas: humidification, heating and filtering from nose to the bronchios for adequate gas exchange occurs in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- oxygen humidification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Dec 2015
- Phase
- Phase 1/2
- 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
- subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula
Who cannot join
- inability to taste saccharin
- nasal surgery
- infection in the last 30 days (before the study)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine University of Sao Paulo
São Paulo, São Paulo, 0124-903
About this study
Official title: Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula on Nasal Mucociliary Clearance, Mucus Properties, Inflammation and Airway Symptoms in Patients
During normal breathing, the upper and lower airways performs the priming of inspired gas: humidification, heating and filtering from nose to the bronchios for adequate gas exchange occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions (cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart failure among others) may develop chronic respiratory failure and require treatment with oxygen therapy. High fractions of inspired oxygen have been associated with deleterious effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the patient with chronic respiratory receives oxygen via nasal cannula to the patient has been applied with and without humidification, however, does not know the effects of these two types of dry and humidified administration on the mucosa of the nose, airways and lungs. The investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7 days 30 days, 12 months and 24 months.
Read the detailed description
After agreeing to the terms of informed consent, the individual will be admitted to the study. The objective of this study was to evaluate the effects of humidified oxygen and not humidified nasal catheter (12-24 hours/day) on the nasal epithelium of patients with chronic respiratory failure by non-invasive tests in 36 volunteers, of both sexes aged ≥ 18 years with a medical indication for the use of home oxygen via nasal cannula on: (1) nasal mucociliary transport through the saccharin test, (2) the physical properties of nasal mucus by simulated cough machine and contact angle, (3) cellularity via nasal and total count differential white blood cell nasal lavage, (4) ph nasal lavage and exhaled breath condensate (5) quantification of cytokines in nasal lavage and (6) quality of life questionnaire with rhinosinusitis (SNOT20). Assessments will be performed at baseline, 12 hours, 7 days, 30 days, 12 months and 24 months of use. Volunteers will be recruited from three Basic Health Supervision of Cathedral Health, City Health Department, City of São Paulo.
- Conditions
- Chronic Respiratory Failure
- Being tested
- oxygen humidification
- Keywords
- Chronic respiratory failure, Oxygen therapy, Nasal catheter, Mucociliary clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen humidificationOther
humidification for oxygen delivered by nasal catheter
| Study group | Role | What they receive |
|---|---|---|
| oxygen humidification | Experimental | Oxygen by nasal catheter delivery will be humidified by bubles. Receives: Other: oxygen humidification |
| Dry oxygen | No intervention | oxygen by nasal catheter delivery will be dry |
What is being measured
The primary outcome is the main question the study is designed to answer.
saccharin transit time test
The investigators evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject is asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.
Measured: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionDec 2015 (estimated)
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 Chronic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Kondo Nakagawa, University of Sao Paulo
- Investigators
- Paulo HN Saldiva, Professor, Study chair, School of Medicine University of Sao PauloNaomi K Nakagawa, Ph.D., Principal investigator, School of Medicine University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515786
- Sponsor's protocol ID
- CEP 041/13
- Status last verified
- Nov 2015
- First submitted
- 26 May 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.
PubMed 27048871
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula on Nasal Mucociliary Clearance, Mucus Properties, Inflammation and Airway Symptoms in Patients
- ClinicalTrials.gov ID
- NCT02515786
- Acronym / sponsor ID
- CEP 041/13
- Conditions
- Chronic Respiratory Failure
- Keywords
- Chronic respiratory failure, Oxygen therapy, Nasal catheter, Mucociliary clearance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Aug 2015 (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.
During normal breathing, the upper and lower airways performs the priming of inspired gas: humidification, heating and filtering from nose to the bronchios for adequate gas exchange occurs in the lungs. Many patients with severe or advanced cardiopulmonary conditions (cystic fibrosis, chronic obstructive pulmonary disease, pulmonary hypertension, advanced heart failure among others) may develop chronic respiratory failure and require treatment with oxygen therapy. High fractions of inspired oxygen have been associated with deleterious effects on the nasal ciliary beating and nose mucociliary transport. At home assistance, the patient with chronic respiratory receives oxygen via nasal cannula to the patient has been applied with and without humidification, however, does not know the effects of these two types of dry and humidified administration on the mucosa of the nose, airways and lungs. The investigators will assess the subject in use of home oxygen therapy at baseline, 12 hours, 7 days 30 days, 12 months and 24 months.
Detailed description
After agreeing to the terms of informed consent, the individual will be admitted to the study. The objective of this study was to evaluate the effects of humidified oxygen and not humidified nasal catheter (12-24 hours/day) on the nasal epithelium of patients with chronic respiratory failure by non-invasive tests in 36 volunteers, of both sexes aged ≥ 18 years with a medical indication for the use of home oxygen via nasal cannula on: (1) nasal mucociliary transport through the saccharin test, (2) the physical properties of nasal mucus by simulated cough machine and contact angle, (3) cellularity via nasal and total count differential white blood cell nasal lavage, (4) ph nasal lavage and exhaled breath condensate (5) quantification of cytokines in nasal lavage and (6) quality of life questionnaire with rhinosinusitis (SNOT20). Assessments will be performed at baseline, 12 hours, 7 days, 30 days, 12 months and 24 months of use. Volunteers will be recruited from three Basic Health Supervision of Cathedral Health, City Health Department, City of São Paulo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen humidification | Experimental | Other: oxygen humidificationOxygen by nasal catheter delivery will be humidified by bubles. |
| Dry oxygen | No intervention | –oxygen by nasal catheter delivery will be dry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects aged ≥ 18 years with a medical indication for the use of home low-flow oxygen via nasal cannula
Key exclusion criteria (3 listed)
- inability to taste saccharin
- nasal surgery
- infection in the last 30 days (before the study)
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 humidificationhumidification for oxygen delivered by nasal catheter | Other | oxygen humidification |
Primary outcome
saccharin transit time test
Time frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy
The investigators evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject is asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Derived from this study: PubMed 27048871Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.
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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.
Paulo HN Saldiva, Professor study chair
School of Medicine University of Sao Paulo
Naomi K Nakagawa, Ph.D. principal investigator
School of Medicine University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oxygen humidification in people with Chronic Respiratory Failure, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
saccharin transit time test (time frame: First baseline measurement, 12 hours, 7 days, 30 days, 12 months and 24 months of use of home oxygen therapy). 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 NCT02515786, 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 24 Nov 2015.