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Clinical Trials/JPRN-jRCTs031180338
JPRN-jRCTs031180338
Completed
Phase 2

The prospective study to evaluate the efficacy of the combination therapy of inhaled budesonide/formoterol fumarate, clarithromycin, and montelukast in AFO after allogeneic SCT - Chiba AFO-01 study

Sakaida Emiko0 sites85 target enrollmentMarch 18, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Air flow obstruction after allogeneic SCT
Sponsor
Sakaida Emiko
Enrollment
85
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 18, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sakaida Emiko

Eligibility Criteria

Inclusion Criteria

  • 1\. The patient who receives the 1st allogeneic stem cell transplantation
  • 2\. The patient who can examine the pulmonary function tests.
  • 3\. PS (ECOG), 0\-2
  • 4\. The patient who has no exceptionable organ problems
  • 1\) serum ALT/AST concentrations:150 IU/L and under
  • 2\) total bilirubin: 3mg/dL and under
  • 3\) CCr:40ml/min or over (by C\-G)
  • 4\) arterial blood oxygen saturation or SpO2 in room air:94% or over
  • 5\. Written informed consent

Exclusion Criteria

  • 1\. Known history of intolerance or allergy to any triplet component.
  • 2\. The patient who has past history of asthma and had attack within one year.
  • 3\. The patient who has already been treated with the triplet combination.
  • 4\. The patient who has active infection
  • 5\. The patient who has mental disability requiring treatment
  • 6\. The patient who has severe thromboembolism, including myocardial infarction, cerebral infarction, and cardiovascular complications.
  • 7\. The patient who has uncontrollable diabetes mellitus and metabolic disease
  • 8\. The patient who has other malignancy requiring anticancer treatment
  • 9\. Pregnancy or nursing.
  • 10\. At the time of enrollment as judged by the enrolling investigator would interfere

Outcomes

Primary Outcomes

Not specified

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