Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation (AHR)

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00771836
First received: May 27, 2008
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

Background: Stem cell transplantation (SCT) is associated with pulmonary complications and may lead to high morbidity and mortality. We encountered several children post-SCT with a clinical picture suggestive of airway hyper-reactivity (AHR) and evidence of reversible airway obstruction that was not reported pre-transplant. Our aim was to determine if SCT induced AHR as assessed by methacholine challenge test (MCT) and to determine any correlation between AHR and pulmonary complications.

Methods: Prospective study evaluating consecutive patients referred for SCT to the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital. Evaluation included pulmonary function test and methacholine challenge test before and after the transplantation, and assessment of pulmonary complications.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airway Reactivity in Children Before and After Bone Marrow Transplantation

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Positive MCT after SCT may be associated with increased risk of pulmonary complications [ Time Frame: 3 years followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients with airway reactivity increased after after SCT (p < 0.05; McNemar test). [ Time Frame: 3 years followup ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Not retained


Enrollment: 39
Study Start Date: July 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

We encountered several children post SCT with clinical picture suggestive of airway hyper-reactivity (AHR) by spirometric evidence of reversible airway obstruction that was not reported pre transplantation. Our question was if AHR is present but undiagnosed pre BMT or AHR is developed post transplantation.

Our aim was to determine if BMT induces AHR as assessed by methacholine challenge test (MCT) and to determine a possible correlation between AHR and pulmonary complications. The study was Prospective. Subjects: consecutive patients were referred for pulmonary function tests (PFT's); MCT and clincical evaluation before SCT and were followed after transplantation for at least a year. The study was approved by the ethics committee and parental consent was obtained. Clnical evaluation included medical history: type of disease, previous chemo/radiotherapy. Type of SCT was recorded (allogeneic/ autologous). respiratory evaluation included: Respiratory history; previous asthma medications; allergy/ parental smoking; Physical exam; CXR O2-Sat. on rest and exercise. PFT's included: Spirometry, lung volumes, diffusion capacity; MCT prior and 2-6 months post SCT; Follow-up: 6-12 months post SCT. Pulmonary complication: Any respiratory symptoms or signs: cough, SOB, hemoptysis, hypoxemia; New chest radiological finding; Number of hospitalizations due to pulmonary complications.

Statistics: Sample size-26 patients to detect an increase of 0.5SD in AHR with a power of 80%. No. of children with AHR before and after SCT.; Pulmonary complications and AHR: hospitalizations for pulmonary complications and AHR.

  Eligibility

Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children who underwent SCT in the Department of Pediatric Hemato-Oncology at Meyer Children's Hospital and were referred to the Pediatric Pulmonary Unit.

Criteria

Inclusion Criteria:

  • age 4.5-20 years
  • ability to perform spirometry consistently
  • FEV1>70% predicted

Exclusion Criteria:

  • FEV1<70%
  • inability to perform methacholine challenge test before and after stem cell transplantation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771836

Locations
Israel
Pediatric Pulmonary Unit, Meyer Children's Hospital of Haifa, Meyer Children's Hospital, Rambam Medical Center, and the Bruce Rappaport Faculty of Medicine
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Lea Bentur, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: no sponsor, Rambam Medical Center, Haifa, Israel
ClinicalTrials.gov Identifier: NCT00771836     History of Changes
Other Study ID Numbers: RambamMC1866CTIL, AHRBMT1866
Study First Received: May 27, 2008
Last Updated: October 14, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Stem cell transplantation
Airway hyper-reactivity
methacholine
pediatric

ClinicalTrials.gov processed this record on July 22, 2014