Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases (COOX)
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|ClinicalTrials.gov Identifier: NCT02831348|
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : March 27, 2018
|Condition or disease|
|Asthma Allergic Rhinitis Cystic Fibrosis Pneumonia|
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 Type :||Observational|
|Estimated Enrollment :||84 participants|
|Official Title:||Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases|
|Actual Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||January 2020|
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.
Indicated by an ACT score of >19, or spirometry results within 10% of year's best value (based on FEV1).
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.
Indicated by a negative history of any of the conditions characterizing the other groups.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831348
|Contact: Jonathan M Gaffin, MD, MMSc||857-218-5379 ext firstname.lastname@example.org|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator: Jonathan M Gaffin, MD, MMSc|