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Airway Reactivity in Children Before and After Bone Marrow Transplantation

4 Years
20 Years
Not Enrolling

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Trial Information

Airway Reactivity in Children Before and After Bone Marrow Transplantation

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Positive MCT after SCT may be associated with increased risk of pulmonary complications

Outcome Time Frame:

3 years followup

Safety Issue:


Principal Investigator

Lea Bentur, MD

Investigator Role:

Study Director

Investigator Affiliation:

Rambam Health Care Campus


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

July 2004

Completion Date:

July 2007

Related Keywords:

  • Cancer
  • Stem cell transplantation
  • Airway hyper-reactivity
  • methacholine
  • pediatric