(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

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 control symptoms. This study will evaluate the impact and severity of
      asthma exacerbations that occur in children with mild persistent asthma who are receiving
      various combinations of medications for daily and rescue use.
    

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 tightness, and coughing. While there is no cure for asthma, most children
      who receive proper treatment are able to control symptoms and lead a normal life. Asthma is
      commonly treated with two types of medications: long-term control medication, such as inhaled
      corticosteroids (ICS), which is taken on a regular schedule to prevent symptoms and keep
      asthma under control, and quick-relief, or "rescue" medication, such as albuterol, which is
      used on an as-needed-basis with the onset of symptoms or an asthma attack. The purpose of
      this study is to assess the impact and severity of asthma exacerbations that occur in
      children with mild persistent asthma who are receiving ICS on a daily basis plus ICS and
      albuterol as rescue medications.

      This study will begin with a 4-week screening period during which participants will be
      monitored while they use an inhaler with a low dose of ICS medication. Study visits will
      occur at study entry and Week 4. Participants will undergo a physical examination, lung
      function and airway pressure testing, and blood collection. At the Week 4 study visit,
      participants will be randomly assigned to one of the following four groups for 44 weeks of
      treatment:

        -  Group 1 will take ICS twice a day and ICS plus albuterol as rescue medication

        -  Group 2 will take ICS twice a day and placebo ICS plus albuterol as rescue medication

        -  Group 3 will take placebo ICS twice a day and ICS plus albuterol as rescue medication

        -  Group 4 will take placebo ICS twice a day and placebo ICS plus albuterol as rescue
           medication

      Each participant will receive three inhalers with their assigned medication. One inhaler will
      be used twice daily throughout the study. The other two inhalers will be used consecutively
      on an as-needed-basis as rescue medication. Study visits will occur at Weeks 8, 16, 24, 32,
      40, and 48. A physical examination, blood collection, and lung function and airway pressure
      testing will occur at selected visits. Questionnaires to assess quality of life and asthma
      control will also be completed. A methacholine challenge test will be completed at some study
      visits. This test artificially triggers an asthma attack to determine the severity of an
      individual's asthma. Throughout the study, participants will record asthma symptoms and
      rescue medication usage in a daily diary.
    

Intervention name(s): Beclomethasone dipropionate; Beclomethasone dipropionate; Albuterol sulfate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid; Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed; Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed
Other intervention name(s): QVAR®; QVAR®; ProAir®
Intervention MeSH terms: Beclomethasone; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment