Lansoprazole to Treat Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a
      condition in which excess stomach acid flows backwards into the esophagus. This study will
      evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in
      improving asthma control and reducing symptoms in children with poorly controlled asthma.
    

Detailed description: 
      Approximately 75% of individuals with asthma also experience GERD. If left untreated, GERD
      can lead to lung damage, esophageal ulcers, or esophageal cancer. Children and adults whose
      asthma is poorly controlled with inhaled corticosteroids are often prescribed drugs that
      suppress gastric acid production; however, this treatment is expensive and has not been
      proven beneficial. Lansoprazole is a proton pump inhibitor medication that reduces stomach
      acid production. It may also decrease the frequency of asthma exacerbations in children with
      poorly controlled asthma. The purpose of this study is to evaluate the effectiveness of
      lansoprazole at improving asthma control, quality of life, and lung function in children with
      asthma.

      This study will enroll children with poor asthma control who are receiving inhaled
      corticosteroids. Participants will be randomly assigned to receive either lansoprazole or
      placebo on a daily basis for 6 months. Study visits will occur at baseline and Weeks 4, 8,
      12, 16, 20, and 24, and participants will be contacted by telephone at Week 2. A physical
      examination, blood collection, and methacholine challenge test will occur at selected visits.
      The methacholine challenge test will be used to help determine the severity of an
      individual's asthma. Lung function and airway pressure testing, questionnaires on asthma
      control and quality of life, medical history review, pill counts, and distribution of
      medication will occur at most study visits. Participants will record asthma symptoms and lung
      function in a daily diary throughout the study. A select group of participants will also wear
      an esophageal potential Hydrogen (pH) monitor for 24 hours to evaluate GERD symptoms and the
      relationship between GERD and asthma symptoms.
    

Intervention name(s): Lansoprazole; Matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.; Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.
Other intervention name(s): Prevacid; Matching placebo manufactured by TAP Pharmaceuticals
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment