Asthma Clinical Trial
— GenARAOfficial title:
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
Verified date | June 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 18, 2024 |
Est. primary completion date | January 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: - Age: 6-17 year olds with documented clinician-diagnosed asthma - Evidence of recent uncontrolled asthma (must meet at least one of the following). This convention for defining poorly-controlled asthma has been successfully used in a large pediatric trial. - ACQ > 1.2 - Use of short-acting beta-agonist for asthma symptoms twice/week or more on average over the past month - Nocturnal awakenings with asthma symptoms more than once per week on average over the last month - Two or more emergency department visits, unscheduled provider visits, prednisone courses or hospitalizations for asthma in the past 12 months - Currently on stable dose of daily inhaled corticosteroid medication (ICS) for asthma control equivalent to 88mcg of fluticasone or greater for at least 6 weeks from the time of enrollment. Participant must be on National Asthma Education and Prevention Program (NAEPP) controller step 2, 3 or 4. - Currently with mild GERD symptoms reported at V1 defined by a score on the Pediatric GERD Symptom Assessment Score greater than 15 and less than 80. GSAS ranges from 0 to >440. Exclusion Criteria: - Taking daily CYP2C19 substrates, inducers or inhibitors medication - Past or current history of moderate-severe GERD or related disorders (erosive esophagitis, peptic ulcer disease, eosinophilic esophagitis) which in the opinion of the pediatric gastroenterology safety specialist/study physician requires treatment with acid-blocking agents; - Daily use of a PPI for more than 4 consecutive weeks in the past 6 months; - previous intubation for asthma, - admission to intensive care unit for more than 24 hours for asthma in the past year, - Previous surgery involving the esophagus or stomach (anti-reflux surgery, peptic ulcer surgery, trachea-esophageal fistula repair); - Forced expiratory volume in 1 second (FEV1) < 60% of predicted at enrollment; - Any major chronic illness that would interfere with participation in the intervention or completion of the study procedures; - History of phenylketonuria (PKU); - Medication use: treatment of GERD symptoms with over-the-counter antacids 4 days/week or more on average over past month; - Theophylline preparations, azoles, anti-coagulants, insulin for Type 1 diabetes, digitalis, oral iron supplements when administered for iron deficiency within 1 month; - Any investigational drugs within the past 2 months; - Drug Allergies: previous allergic reaction from lansoprazole or other proton pump inhibitor medication or adverse reaction to aspartame; - Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or site PI; - Less than 75% completion of daily diary for asthma symptoms, SABA use and ICS medication adherence during the run-in period; - Plan for family to move from study location within the next 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | Nemours Children's Specialty Care | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Jason Lang, M.D., M.P.H. | Nemours Children's Clinic, Thrasher Research Fund |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Asthma Control Questionnaire (ACQ) from Screening through Week 26 | The ACQ considers a broad set of common indicators of asthma control including use of bronchodilators, cough, nocturnal symptoms, level of activity, and pulmonary function. | Measured at weeks -2 (screening), 0 (baseline), 8, 16, 26 | |
Secondary | Change in GERD Symptom Assessment Questionnaire Score (GSAS) from Screening through Week 26 | A 10-item tool that has been validated in children in the assessment of gastroesophageal reflux disease related symptoms such as chest/abdominal pain, pain/choking with eating, swallowing dysfunction, regurgitation and nausea. It assesses symptom frequency and severity from the previous 7-days on an 8-point scale with 0 and 7 indicating the least and greatest severity, respectively. | Measured at weeks -2 (screening), 0 (baseline), 4, 8, 12,16, 20, 26 | |
Secondary | Change in Asthma Symptom Utility Index (ASUI) from Screening through Week 26 | Questionnaire measures changes in asthma control. | Measured at weeks -2 (screening), 0 (baseline), 8, 16, 26 | |
Secondary | Annualized rate of asthma exacerbations | An exacerbation will be defined per the recommendations of the NIH Asthma Exacerbation Taskforce and will be defined as a worsening of asthma requiring the use of a systemic corticosteroid (at least 3 days of prednisolone/ prednisone or =1 days of dexamethasone) to prevent asthma worsening. | Week 0 (baseline) through Week 26 | |
Secondary | Annualized rate of Episodes of Poor Asthma Control (EPAC) | A study EPAC will be present if the participant meets any of the following criteria, (1) addition of systemic corticosteroid medication for asthma as above, (2) any unscheduled visit to a non-study related health care provider (ED, urgent care, hospital) for asthma symptoms, (3) increased use of rescue Short-Acting Beta Agonists (SABA) by more than 4 additional puffs (or more than 2 additional nebulizations) above baseline amount determined at enrollment. | Week 0 (baseline) through Week 26 | |
Secondary | Annualized rate of respiratory tract infection (RTI) | Participants/Caregivers will be asked to document symptoms of RTI on daily diary cards per consensus definitions. RTI symptoms will include: (1) runny nose; (2) stuffy or blocked nose or noisy breathing; (3) cough; (4) fever, feels hot, or has chills; (5) sore throat; and (6) sneezing. | Week 0 (baseline) through Week 26 | |
Secondary | Change in Lung Function Testing from Screening through Week 26 | Forced Expiratory Volume in 1 Second (FEV1) measurement | Measured at week -2 (screening), week 26 |
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