Status:
COMPLETED
(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Asthma is a common, serious illness among children in the United States. It can be effectively controlled through the use of preventative medications and "rescue" medications, which are used to contro...
Detailed Description
Almost 9 million children in the United States have asthma, and it is a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest ti...
Eligibility Criteria
Inclusion
- Able to perform reproducible spirometry according to American Thoracic Society (ATS) criteria
- History of asthma symptoms that are adequately controlled in the 4 weeks prior to study entry, and meets at least one of the following criteria:
- History of mild persistent asthma symptoms (on average greater than 2 days per week with symptoms or albuterol use for symptoms or greater than 2 night-time awakenings per month during the year prior to study entry) and has been treated with a single-controller inhaled corticosteroid (ICS) dose less than or equal to 160 mcg per day of a beclomethasone-equivalent or a leukotriene receptor antagonist (LTRA) (in an age-appropriate dose) for the 4 weeks prior to study entry; individuals treated with a combination controller therapy (e.g. ICS+LTRA or ICS+long-acting beta-agonist (LABA)) in the past 8 weeks will not be eligible
- Not currently being treated with ICS, a history of mild persistent asthma, and 1 to 2 exacerbations in the year prior to study entry (but none in the 3 months prior to study entry)
- Forced expiratory volume in one second (FEV1) reversibility of greater than or equal to 12% following bronchodilator administration (4 puffs); individuals who do not meet this requirement may qualify for enrollment if their methacholine provocative concentration at 20% (PC20) is less than or equal to 12.5 milligrams per milliliter (mg/ml)
- History of clinical varicella or varicella vaccine; individuals needing the vaccine may receive it from their primary care physician prior to study entry
- Ability of parent to provide informed consent; verbal assent must be obtained from children less than 7 years of age and written assent must be obtained from children between 7 and 18 years of age
- If female, willing to use an effective form of contraception
- Participants will be eligible for the 44 weeks of treatment if, after the 4-week screening period, their asthma remains controlled, and they demonstrate at least 80% predicted pre-bronchodilator FEV1. Participants must meet ALL of the criteria stated below during the 8-week screening period to continue in the study:
- Meets the definition of acceptable asthma control, which is NOT having one or more of the following during ANY 2-week period:
- On average, on more than 2 days per week, experiences one or more of the following:
- Diary-reported symptoms
- The use of inhaled bronchodilator (not including pre-exercise)
- Peak flows in the yellow zone (less than 80% of personal best defined as based on peak expiratory flow (PEF) value obtained at study visit 1
- More than 1 night-time awakening due to asthma
- Demonstrates adherence with taking study medications (at least 75% of scheduled doses), rescue medications (using both rescue inhalers for at least 75% of rescue doses), and completing patient diaries (at least 75% of days)
- Pre-bronchodilator FEV1 greater than or equal to 80% predicted at study visits 2 and 3
- Agrees to not use a spacer with beclomethasone/placebo study and rescue medications
- NOTE: In January 2008, the Data and Safety Monitoring Board (DSMB) approved changes in the TREXA eligibility criteria, by which neither FEV1 reversibility ≥ 12% nor a participant's methacholine PC20 ≤ 12.5 mg/ml were required for randomization.
Exclusion
- Corticosteroid treatment for any condition prior to study entry within the following defined timepoints:
- Oral - Use within 2-week period of the screening visit
- Injectable - Use within 2-week period of the screening visit
- Nasal corticosteroids may be used at any time during the study at the discretion of the study investigator or primary care physician
- Current or prior use of medications known to significantly interact with corticosteroid disposition (within a 2-week period of study visit 1), including but not limited to carbamazepine, erythromycin or other macrolide antibiotics, phenobarbital, phenytoin, rifampin, or ketoconazole
- Pre-bronchodilator FEV1 less than 60% predicted at study visit 1
- Any hospitalization for asthma in the year prior to study entry
- Presence of chronic or active lung disease other than asthma
- Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study
- History of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
- Any asthma exacerbation in the past 3 months or more than 2 in the past year.
- History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure
- History of adverse reactions to ICS preparations or any of its ingredients
- Receiving hyposensitization therapy other than an established maintenance regimen (continuous regimen for at least 3 months)
- Pregnant or breastfeeding
- Cigarette smoking or smokeless tobacco use in the year prior to study entry
- Refusal to consent to a genotype evaluation
- Current participation or participation within 1 month of study entry in another investigational drug trial
- Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before study completion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00394329
Start Date
November 1 2006
End Date
December 1 2011
Last Update
July 2 2018
Active Locations (6)
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1
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
2
Los Angeles, Kaiser Permanente Allergy Department
Los Angeles, California, United States, 90027
3
Kaiser Permanente Medical Center
San Diego, California, United States, 92111
4
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206