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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00675584 |
Asthma affects about 4 million children in the United States and is a leading cause of hospitalizations and school absenteeism. Continuous wheezing in very young children may develop into asthma. Low doses of inhaled corticosteroids (ICS) are commonly prescribed to treat children with particularly bad wheezing episodes. This study will compare the safety and effectiveness of low doses of ICS taken daily versus higher doses of ICS taken only during respiratory tract illnesses for toddlers with continuous wheezing or coughing illnesses.
Condition | Intervention | Phase |
Asthma |
Drug: Budesonide Drug: Placebo Budesonide |
Phase III |
MedlinePlus related topics: | Asthma Caregivers |
Drug Information available for: | Budesonide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Childhood Asthma Research and Education (CARE) Network Trial - Maintenance Versus Intermittent Inhaled Steroids in Wheezing Toddlers (MIST) |
Estimated Enrollment: | 250 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Participants will receive 0.5 mg of ICS (budesonide as Pulmicort Respules®) once a day at night, except during respiratory tract illnesses. During respiratory tract illnesses, participants will receive placebo each morning and 0.5 mg of budesonide each night for 7 days.
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Drug: Budesonide
Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.
Drug: Placebo Budesonide
Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.
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2: Experimental
Participants will receive 1 mg of ICS (budesonide as Pulmicort Respules®) twice a day for 7 days at the onset of a respiratory tract illness; they will receive placebo ICS once a day at all other times during the study.
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Drug: Budesonide
Participants in Arm 1 will receive 0.5 mg of budesonide once a day. Participants in Arm 2 will receive 1 mg of budesonide twice a day for 7 days at the onset of respiratory tract illnesses.
Drug: Placebo Budesonide
Participants in Arm 1 will receive placebo budesonide each morning during respiratory tract illnesses for 7 days. Participants in Arm 2 will receive placebo budesonide once a day for the entire study, other than when they have a respiratory tract illness.
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Childhood asthma can be caused by many factors, including allergens, cigarette smoke, air pollution, or infections. Symptoms include wheezing, shortness of breath, chest tightness, and coughing. Wheezing illnesses are common during the first several years of life, and continuous wheezing, or recurrent intermittent wheezing, may be an indicator of asthma. Recurrent intermittent wheezing can also lead to breathing difficulties, sleep disturbances, and severe exacerbations that result in emergency department visits, hospitalizations, or even death. The Prevention of Early Asthma in Kids (PEAK) and Acute Intervention Management Strategies (AIMS) studies, both of which are part of the Childhood Asthma Research and Education (CARE) Network, as well as several other studies, have identified therapies that may improve recurrent wheezing in young children. This study will compare the safety and effectiveness of two treatment regimens—low doses of ICS taken on a daily basis versus higher doses of ICS taken only during respiratory tract illnesses—at improving recurrent wheezing in toddlers. Study researchers will also identify individual characteristics (e.g., age, gender, family history of asthma and allergies, the degree of allergy, genetics) that may be associated with treatment response. Lastly, the relationship of virus infections to respiratory illnesses, wheezing episodes, and response to study treatments will also be studied.
This study will enroll children between 12 and 47 months of age who have experienced at least four episodes of wheezing or coughing in the year before study entry, with at least one episode that required one of the following: oral steroids, an urgent unscheduled medical visit, an emergency room visit, or hospitalization. This study will begin with a 2-week evaluation period during which potential participants will receive placebo once a day. Parents will document their child's asthma symptoms and medication use in a daily diary. Next, at a baseline study visit, eligible participants will be randomly assigned to one of the following two 12-month treatment groups:
Throughout the 12 months of treatment, all participants will receive albuterol to treat respiratory symptoms and prednisolone if asthma symptoms worsen. Parents will be given an action plan to help manage their child's symptoms, and during respiratory illnesses, parents will contact study researchers to determine the best treatment plan. Study visits will occur at baseline and Weeks 4, 12, 20, 28, 36, 44, and 52. Participants' parents will take part in scheduled telephone interviews one month after each clinic visit to provide information on their child's asthma symptoms, study medication use, and health problems. Most study visits will include a physical exam and lung function testing. At select study visits, the following will occur: allergy skin testing, blood collection, nasal mucus sampling, and parent questionnaires to assess asthma, quality of life, and environmental factors. A portion of the participants' blood will undergo genetic analysis; a blood collection from parents for genetic analysis will be optional. Throughout the treatment period, participants' parents will record asthma symptoms and medication usage in a daily diary.
Ages Eligible for Study: | 12 Months to 47 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria at Screening Visit:
Participants who meet all of the following criteria are eligible for study entry. Participants may be reassessed if not initially eligible.
Exclusion Criteria at Screening Visit:
Participants who meet any of the following criteria are NOT eligible for enrollment, but they may be re-enrolled if these exclusion criteria disappear:
Participants who meet any of the following criteria are NOT eligible for enrollment, and they may not be re-enrolled:
Exclusion Criteria at Baseline Visit:
Participants will be ineligible to continue in the study and be randomly assigned to a treatment group if any of the following is documented during the 2-week observation period, but they may be re-enrolled if these exclusion criteria disappear:
United States, Arizona | |||||
University of Arizona College of Medicine | Recruiting | ||||
Tucson, Arizona, United States, 85724 | |||||
Contact: Fernando D. Martinez, MD 520-626-6387 fernando@resp-sci.arizona.edu | |||||
Contact: Wayne Morgan, MD 520-626-7780 wmorgan@resp-sci.arizona.edu | |||||
Principal Investigator: Fernando D. Martinez, MD | |||||
United States, California | |||||
Kaiser Permanente Medical Center | Recruiting | ||||
San Diego, California, United States, 92111 | |||||
Contact: Robert S. Zeiger, MD, PhD 858-573-5408 robert.s.zeiger@kp.org | |||||
Contact: Gregory P. Heldt, MD 619-543-3790 gheldt@ucsd.edu | |||||
Principal Investigator: Robert S. Zeiger, MD, PhD | |||||
United States, Colorado | |||||
National Jewish Medical and Research Center | Recruiting | ||||
Denver, Colorado, United States, 80206 | |||||
Contact: Stanley J. Szefler, MD, PhD 303-398-1193 szeflers@njc.org | |||||
Contact: Gary Larsen, MD 303-398-1617 larseng@njc.org | |||||
Principal Investigator: Stanley J. Szefler, MD, PhD | |||||
United States, Missouri | |||||
Washington University School of Medicine | Recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Contact: Robert C. Strunk, MD 341-454-2284 strunk@kids.wustl.edu | |||||
Contact: Leonard Bacharier, MD 314-454-4233 bacharier_l@kids.wustl.edu | |||||
Principal Investigator: Robert C. Strunk, MD | |||||
United States, Wisconsin | |||||
University of Wisconsin - Madison | Recruiting | ||||
Madison, Wisconsin, United States, 53792 | |||||
Contact: Robert F. Lemanske, Jr., MD 608-265-2206 rfl@medicine.wisc.edu | |||||
Contact: Christine A. Sorkness, PharmD 608-263-2866 sorkness@facstaff.wisc.edu | |||||
Principal Investigator: Robert F. Lemanske, Jr., MD |
Principal Investigator: | David T. Mauger, PhD | Penn State College of Medicine |
Principal Investigator: | Stanley J. Szefler, MD, PhD | National Jewish Medical and Research Center |
Principal Investigator: | Robert F. Lemanske, Jr., MD | University of Wisconsin, Madison |
Principal Investigator: | Robert S. Zeiger, MD, PhD | Kaiser Permanente Medical Center |
Principal Investigator: | Robert C. Strunk, MD | Washington University School of Medicine |
Principal Investigator: | Fernando D. Martinez, MD | University of Arizona College of Medicine |
Study Chair: | Lynn M. Taussig, MD | University of Denver |
Click here for the Childhood Asthma Research and Education (CARE) Network Web site 
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Responsible Party: | The Pennsylvania State University, College of Medicine ( David T. Mauger, PhD ) |
Study ID Numbers: | 581, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307 |
First Received: | May 7, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00675584 |
Health Authority: | United States: Food and Drug Administration |
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