Airway Reactivity in Children Before and After BMT Bone Marrow Transplantation

Cancer Clinical Trial

— AHR  

Official title:

Airway Reactivity in Children Before and After Bone Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771836
• Other study ID #: RambamMC1866CTIL
• Secondary ID: AHRBMT1866
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: October 14, 2008
• Start date: July 2004
• Est. completion date: July 2007

Study information

• Verified date: October 2008
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 20 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive MCT after SCT may be associated with increased risk of pulmonary complications		3 years followup	No
Secondary	The number of patients with airway reactivity increased after after SCT (p < 0.05; McNemar test).		3 years followup	No