Study of Acid Reflux Therapy for Children With Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 16 |
| Updated: | 1/1/2014 |
| Start Date: | September 2006 |
| End Date: | December 2011 |
| Contact: | Denise Whitlock |
| Email: | denise_whitlock@oz.ped.emory.edu |
| Phone: | 404-717-1733 |
Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchspasm,
and increase airway reactivity. Children with asthma are often treated for GER with drugs to
supress gastric acid production. However, this treatment is expensive, and with unproven
benefit. The primary objective of this study is to conduct a multi-site, randomized,
clinical trial to test the hypothesis that treatment of GER with lansoprazole, an approved
proton pump inhibitor, will decrease the frequency of exacerbations in children with poorly
controlled asthma. The study will include300 asthmatic children treated with inhaled
corticosteroids, 6-16 years of age, with poor control defined by frequent symptoms,
excessive beta agonist use, or frequent exacerbations. Participants will be randomly
assigned to treatment with either lansoprazole or placebo for 6 months. The presence,
severity, and relationship of GER to asthma symptoms will be determined with 24 hour
esophageal pH monitoring, but randomization to treatment will not be influenced by the
presence or severity of GER. The primary outcome measure is the proportion of participants
who have exacerbations of asthma defined by diaries and interviews. Secondary outcome
measures include asthma symptom and control scores, GER symptoms, lung function, and
unscheduled health care contacts. Pre-defined subgroup analyses will examine the
relationship between specific clinical features and the response to lansoprazole. Treatment
response will also be evaluated with 3-hour post-dose plasma lansoprazole concentrations,
and related to polymorphisms in CYP2C19, the cytochrome P450 pathway, and IL-1 beta, a
pro-inflammatory cytokine. Tertiary studies will determine how the magnitude of GER impacts
airways inflammation, as measured by the concentrations of H+ (pH) and NO in expired breath.
The results of this trial sould have a major impact on the understanding and treatment of
GER in children with asthma.
and increase airway reactivity. Children with asthma are often treated for GER with drugs to
supress gastric acid production. However, this treatment is expensive, and with unproven
benefit. The primary objective of this study is to conduct a multi-site, randomized,
clinical trial to test the hypothesis that treatment of GER with lansoprazole, an approved
proton pump inhibitor, will decrease the frequency of exacerbations in children with poorly
controlled asthma. The study will include300 asthmatic children treated with inhaled
corticosteroids, 6-16 years of age, with poor control defined by frequent symptoms,
excessive beta agonist use, or frequent exacerbations. Participants will be randomly
assigned to treatment with either lansoprazole or placebo for 6 months. The presence,
severity, and relationship of GER to asthma symptoms will be determined with 24 hour
esophageal pH monitoring, but randomization to treatment will not be influenced by the
presence or severity of GER. The primary outcome measure is the proportion of participants
who have exacerbations of asthma defined by diaries and interviews. Secondary outcome
measures include asthma symptom and control scores, GER symptoms, lung function, and
unscheduled health care contacts. Pre-defined subgroup analyses will examine the
relationship between specific clinical features and the response to lansoprazole. Treatment
response will also be evaluated with 3-hour post-dose plasma lansoprazole concentrations,
and related to polymorphisms in CYP2C19, the cytochrome P450 pathway, and IL-1 beta, a
pro-inflammatory cytokine. Tertiary studies will determine how the magnitude of GER impacts
airways inflammation, as measured by the concentrations of H+ (pH) and NO in expired breath.
The results of this trial sould have a major impact on the understanding and treatment of
GER in children with asthma.
Inclusion Criteria:Age:
- 6-16 years
- Asthma: Physician diagnosed asthma, mathacholine PC20<16 mg/ml, treatment with a
stable dose of daily inhaled corticosteroid equivalent to 200 micrograms/day of
fluticasone or greater for 8 weeks or longer
- Poor asthma control: Use of beta-agonist for asthma symptoms twice/week or more,
nocturnal awakening with asthma symptoms more than once per week, 2 or more emergency
department, unscheduled physician visit, prednisone course, or hospitalizations for
asthma in the past 12 months, Score of 1.5 or greater on the Juniper Scale of Recent
Asthma Control
- Absence of GERD symptoms: No symptoms clearly attributed to GER at the time of
enrollment.
Exclusion Criteria:
- Surgery: Previous anti-reflux or peptic ulcer surgery, previous tracheo-esophageal
fistula repair
- Pulmonary Function:FEV1 <60% predicted normal as measured immediately before
methacholine bronchoprovocation. Methacholine bronchoprovocation limited to
participants with an FEV1 >70% of predicted in accordance with FDA indication
- Other major chronic illnesses: Any major chronic illness including but not limited to
non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell
anemia, endocrine disease, congenital heart disease, congestive heart failure,
stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure,
liver disorders, immunodeficiency states, significant neurodevelopmental delay or
behavioral disorders or other conditions that would interfere with participation in
the study.
- Medication Use: Anti-reflux medication (proton pump inhibitors, H2 blockers,
bethanecol, metaclopromide) within 1 month; Theophylline preparations, azoles,
anti-coagulants, insulin, digitalis, any investigative drug within 2 months.
- Drug allergy: Previous adverse effects from lansoprazole, other proton pump
inhibitors or methacholine challenge.
- Non-adherence: Inability or unwillingness of the legal guardian to provide consent or
inability or unwillingness of the child to provide assent. Inability to swallow study
medication. Inability to perform baseline measurements. Less than 80% completion of
screening period diaries. Inability to contact by telephone. Intention to move out of
the areqa within 6 months. No pregnancy.
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