AsthmaCOOXNCT02831348
Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
An observational study of Asthma and Allergic Rhinitis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions. Read more about this study
- Who is it for?
- Ages 6 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis, Cystic Fibrosis
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2021
- Phase
- Observational
- 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 6 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Age range 6-24years old. All genders, races, and ethnicities were sampled, provided they could complete the study requirements.
Who may be able to join
- diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group)
- Ability to complete study procedures
Who cannot join
- Cardiopulmonary disease outside of the specific conditions for inclusion
- Prematurity
- Congenital heart disease
- Current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection
- Recent serious bacterial infection (except for pneumonia in the pneumonia group)
- Concurrent clinical chest X-ray with findings other those that expected for the group (i.e. normal chest X-ray in pneumonia group or suspected pneumonia on chest X-ray in asthma group). To be determined by attending radiologist's interpretation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions.
Read the detailed description
Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited.
Subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. Transcutaneous carboxyhemoglobin will be recorded.
This study is cross-sectional and will only require one visit coinciding with the clinical visit. Analysis will determine the pairwise differences in SpCO between conditions tested.
- Conditions
- Asthma, Allergic Rhinitis, Cystic Fibrosis, Pneumonia
- Keywords
- Asthma, Allergic rhinitis, Rhinitis, Pneumonia, Cystic fibrosis
- Medical subject headings
- Asthma, Rhinitis, Allergic, Cystic Fibrosis, Pneumonia, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uncontrolled asthma | Indicated by an asthma control test (ACT) score of <20 and asthma symptoms of cough, wheeze, or chest tightness for more than 2 days in the prior 2 weeks, OR current asthma exacerbation indicated by the prescription of a short course (3-5 days) of systemic corticosteroids by treating provider at the time of visit. | |
| Controlled asthma | Indicated by an ACT score of >19, or spirometry results within 10% of year's best value (based on FEV1). | |
| Pneumonia | Indicated by an admission diagnosis of pneumonia with chest X-ray consistent with the diagnosis, based on attending radiologist's interpretation. | |
| Controlled allergic rhinitis | Indicated by a rhinitis control assessment test (RCAT) score of >= 21. | |
| Uncontrolled allergic rhinitis | Indicated by an RCAT score of <21. | |
| Cystic fibrosis (exacerbated) | Indicated by treating physician's assessment of cystic fibrosis respiratory exacerbation within 24 hours of initial antibiotic therapy. | |
| Cystic fibrosis (stable) | Indicated by diagnosis of cystic fibrosis with baseline symptoms and with spirometry results (based on FEV1) within 5% of year's best value. | |
| Control | Indicated by a negative history of any of the conditions characterizing the other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpCO comparison: uncontrolled asthma v. other groups
A pairwise comparison of mean SpCO will be performed between asthma exacerbation group and each other group, e.g., asthma exacerbation v. stable asthma, asthma exacerbation v. pneumonia, etc. An independent t-test will be used to determine statistical significance of the difference of means.
Measured: Time of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan M. Gaffin, Boston Children's Hospital
- Investigators
- Jonathan Gaffin, MD. MMSc., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831348
- Sponsor's protocol ID
- ChildrenH
- Acronym
- COOX
- Status last verified
- Sep 2022
- First submitted
- 11 Jul 2016
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
- ClinicalTrials.gov ID
- NCT02831348
- Acronym / sponsor ID
- COOX / ChildrenH
- Conditions
- Asthma, Allergic Rhinitis, Cystic Fibrosis, Pneumonia
- Keywords
- Asthma, Allergic rhinitis, Rhinitis, Pneumonia, Cystic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 13 Jul 2016 (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.
This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions.
Detailed description
Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited.
Subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. Transcutaneous carboxyhemoglobin will be recorded.
This study is cross-sectional and will only require one visit coinciding with the clinical visit. Analysis will determine the pairwise differences in SpCO between conditions tested.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Uncontrolled asthma | – | –Indicated by an asthma control test (ACT) score of <20 and asthma symptoms of cough, wheeze, or chest tightness for more than 2 days in the prior 2 weeks, OR current asthma exacerbation indicated by the prescription of a short course (3-5 days) of systemic corticosteroids by treating provider at the time of visit. |
| Controlled asthma | – | –Indicated by an ACT score of >19, or spirometry results within 10% of year's best value (based on FEV1). |
| Pneumonia | – | –Indicated by an admission diagnosis of pneumonia with chest X-ray consistent with the diagnosis, based on attending radiologist's interpretation. |
| Controlled allergic rhinitis | – | –Indicated by a rhinitis control assessment test (RCAT) score of >= 21. |
| Uncontrolled allergic rhinitis | – | –Indicated by an RCAT score of <21. |
| Cystic fibrosis (exacerbated) | – | –Indicated by treating physician's assessment of cystic fibrosis respiratory exacerbation within 24 hours of initial antibiotic therapy. |
| Cystic fibrosis (stable) | – | –Indicated by diagnosis of cystic fibrosis with baseline symptoms and with spirometry results (based on FEV1) within 5% of year's best value. |
| Control | – | –Indicated by a negative history of any of the conditions characterizing the other groups. |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Age range 6-24years old. All genders, races, and ethnicities were sampled, provided they could complete the study requirements.
Key inclusion criteria (2 listed)
- diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group)
- Ability to complete study procedures
Key exclusion criteria (6 listed)
- Cardiopulmonary disease outside of the specific conditions for inclusion
- Prematurity
- Congenital heart disease
- Current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection
- Recent serious bacterial infection (except for pneumonia in the pneumonia group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SpCO comparison: uncontrolled asthma v. other groups
Time frame: Time of visit
A pairwise comparison of mean SpCO will be performed between asthma exacerbation group and each other group, e.g., asthma exacerbation v. stable asthma, asthma exacerbation v. pneumonia, etc. An independent t-test will be used to determine statistical significance of the difference of means.
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 22 Sep 2022.
- 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.
Jonathan Gaffin, MD. MMSc. principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergic Rhinitis, run by Boston Children's Hospital at 1 site in United States.
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 2 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 22 Sep 2022. 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 United States. 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?
SpCO comparison: uncontrolled asthma v. other groups (time frame: Time of visit). 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 2022.