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Reflux Disease Therapy in the Management of Childhood Asthma-data Entry and Analysis Only

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Children's Center for Digestive Health Care
ClinicalTrials.gov Identifier:
NCT01536457
First received: December 29, 2011
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

There have been a number of studies which attribute causality between reflux disease and asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed some light on this dilemma, with recent studies suggesting that the association is not as clear. This "retrospective" analysis of a prospective study which treated mod-severe asthmatics with lansoprazole or placebo will enter the collected raw data into a database, then perform statistical analyses to determine if children with asthma treated with acid suppression improved their asthma compared to those receiving placebo.


Condition
Asthma
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Data Analysis of a Randomized, Double-Blind, Placebo- Controlled Study of Gastroesophageal Reflux Disease Therapy (Lansoprazole; Solutab™) in the Management of Childhood Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma GERD
U.S. FDA Resources

Further study details as provided by Children's Center for Digestive Health Care:

Primary Outcome Measures:
  • Asthma exacerbations in the treatment group [ Time Frame: Over 21 months ] [ Designated as safety issue: No ]
    This is a retrospective study. We will be entering data collected in a prospective clinical trial and then analyzing such data to determine if intervention with acid suppression, lansoprazole improves the number of asthma exacerbation in a one year period compared to those receiving placebo.


Enrollment: 59
Study Start Date: July 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This is a retrospective study. The study will simply be taking data collected during a prospective study and analyzing that data. There will be no subjects enrolled in this retrospective study. The subjects enrolled in the prospective study were children, ages 4 to 11 years of age.

Criteria

Inclusion Criteria:

  • Patients who were enrolled in the study, "Randomized, Double-blind, Placebo Controlled Study of Gastroesophageal Reflux Disease Therapy (Lansoprazole; Solutab™) in the Management of Childhood Asthma" will be entered into this database. Only these patients will be included in this study, all other patients will be excluded.

Exclusion Criteria:

  • Patients who were not enrolled in the study, "Randomized, Double-blind, Placebo Controlled Study of Gastroesophageal Reflux Disease Therapy (Lansoprazole; Solutab™) in the Management of Childhood Asthma" will not be included in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536457

Locations
United States, Georgia
Children's Center for Digestive Health Care
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Children's Center for Digestive Health Care
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Benjamin D Gold, M.D. Children's Center for Digestive Health Care
  More Information

No publications provided

Responsible Party: Children's Center for Digestive Health Care
ClinicalTrials.gov Identifier: NCT01536457     History of Changes
Other Study ID Numbers: BG-LAN-2011
Study First Received: December 29, 2011
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Center for Digestive Health Care:
asthma
children
gastroesophageal reflux
retrospective
data analysis

Additional relevant MeSH terms:
Asthma
Gastroesophageal Reflux
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013