Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Asthma is a common, serious illness among children in the United States. While a low dose of
      inhaled corticosteroids (ICS) may effectively control symptoms, some children may require
      additional medications to maintain adequate asthma control. This study compares the
      effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA)
      medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at
      reducing the impact and severity of asthma exacerbations that occur in children with mild to
      moderate persistent asthma.
    

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. Low doses
      of ICS are commonly prescribed to prevent symptoms and keep asthma under control. While this
      is usually sufficient to prevent asthma attacks, some children do not respond well to low
      dose ICS alone. For these children, their asthma symptoms may be more effectively controlled
      by either receiving a higher dose of ICS or receiving LABA or LTRA medications in combination
      with a low dose of ICS. Both LABA and LTRA medications are used to help control moderate to
      severe asthma. The purpose of this study is to compare the effectiveness of a high dose of
      ICS versus a low dose of ICS plus either LABA or LTRA medication at improving asthma control
      and reducing the severity of symptoms that occur in children with mild to moderate persistent
      asthma.

      This study began with an 8-week screening period during which participants were monitored
      while they used an inhaler with a low dose of ICS medication. During this time, participants
      also attended one or two study visits. At each visit, participants underwent a physical
      examination, exhaled nitric oxide analysis, and lung function and airway pressure testing.
      After enrollment criteria were met, participants underwent these same evaluations again, and
      they completed questionnaires to assess asthma control, quality of life, and home
      environmental factors. Blood was collected and a methacholine challenge test was completed,
      which artificially triggers an asthma attack to determine the severity of an individual's
      asthma. Participants then were randomly assigned to one of six treatment sequences, each of
      which includes the following three regimens in a different order:

        -  Low dose of ICS and salmeterol, a LABA medication

        -  Low dose of ICS and montelukast, a LTRA medication

        -  Double dose of ICS

      Each treatment period lasted 16 weeks, with study visits occurring weekly. A physical
      examination, blood collection, lung function and airway pressure testing, a methacholine
      challenge test, and questionnaires occurred at selected visits. Throughout the study,
      participants recorded asthma symptoms, peak expiratory flow rates, and rescue medication
      usage in a daily diary. The entire length of the study did not exceed 56 weeks.
    

Intervention name(s): fluticasone propionate + montelukast; fluticasone propionate; fluticasone propionate + salmeterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck); Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline); Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
Other intervention name(s): Flovent Diskus® + Singulair®; Flovent Diskus®; Advair Diskus®
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment