Agricultural Health Study Follow-up
NCT01399411
Asthma, Autoimmune Diseases
Iowa City, Illinois, United States
View Trial DetailsNCT Number: NCT02013076
The aim of the prospective cohort study is to: (1) document the magnitude of response to oral corticosteroids administered to children presenting to the emergency department with moderate or severe asthma and (2) quantify clinically available potential determinants of the response to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.
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Notify Me1 year–17 year
All sexes
Observational
Children's Hospital of London Health Sciences Centre, London, Ontario, Canada
The objective of the large multicentre cohort study is to quantify the response to oral corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe asthma exacerbation.
The main outcome is hospital admission within 72 hours of the oral corticosteroid administration.
Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM), length of active treatment and other markers of response to therapy in the ED as well as markers of recovery over the next 10 days.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(i) prior diagnosis of asthma made by a physician; OR (ii) prior documented episode of acute cough, wheezing and/or dyspnea with significant response to inhaled β2-agonists or to oral corticosteroids; OR (iii) in a child aged <2 years, 3 or more episodes of cough, wheezing and/or dyspnea, including the index visit; OR (iv) previous lung function tests showing significant reversibility post-bronchodilation (≥12% FEV1 or ≥25% Rrs at 4 to 8 Hz); OR (v) a positive provocation test (PC20 ≤8 mg/mL or Provocation Dose (to increase Rrs by 50% or more (PD50) ≤8 mg/mL), OR (vi) the current episode diagnosed or suspected of asthma by the emergency physician?
Exclusion criteria
Time frame: 72 hours after oral corticosteroids administration
Hospital admission or Length of active treatment for 8 or more hours after the oral corticosteroid administration or ED return visit associated with hospital admission within 72 hours after the oral corticosteroid administration or ED return visit associated within 72 hours with length of active treatment for 8 or more hours after the oral corticosteroid administration
Time frame: 8 hours after oral corticosteroid administration
Time frame: Within 4 hours of oral corticosteroid administration
Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration
Time frame: Within 4 hours of oral corticosteroid administration
Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS
Time frame: Within 8 hours of oral corticosteroid administration
Time until PRAM score ≤ 3
Time frame: Within 4 hours of oral corticosteroid administration
Change in respiratory resistance between baseline and disposition will be documented on the MasterScreen Impulse Oscillometry (Cardinal Health Canada, Montreal, Canada) using previously described standardized techniques in cooperative children aged ≥3 years. (measured in a subset of individuals)
Time frame: Within 7 days of the index ED exacerbation
unscheduled visits for asthma as reported by parents and confirmed by medical charts.
Time frame: Within 7 days of the index ED exacerbation
Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Duration of symptoms measured daily on the validated Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children
Time frame: Within 7 days of the index ED exacerbation
Number of children with vomiting, serious Infection, psychosis, and mood disturbances
Time frame: Within 7 days of the index ED exacerbation
Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity
St. Justine's Hospital
Other
Acronym: DOORWAY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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