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Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status

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ClinicalTrials.gov Identifier: NCT00656916
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : April 11, 2008
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The goal of this clinical research study is to compare lung function of patients who inhale steroids in the early stages of post-transplant constrictive bronchiolitis (PTCB) to patients who continue with standard of care.

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: Fluticasone Propionate Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Early Treatment With Inhaled Corticosteroids Versus Observation for Patients Who Have Decreased Lung Function Status Post Allogeneic Stem Cell Transplantation
Study Start Date : March 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010


Arms and Interventions

Arm Intervention/treatment
Experimental: Fluticasone Propionate
440 micrograms twice daily by oral inhalation.
Drug: Fluticasone Propionate
440 micrograms twice daily by oral inhalation.
No Intervention: Observational Group
Comparator group, no intervention.


Outcome Measures

Primary Outcome Measures :
  1. Lung Function Non-deterioration Rate [ Time Frame: Baseline and three months ]
    Lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 20%. FEV1, maximal amount of air forcefully exhaled in 1 second, converted to percentage of normal, calculated from a pulmonary function test (PFT) performed at baseline and three months.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients >/=18 years of age.
  2. Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation.
  3. New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%.
  4. Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease.
  5. Patient must be willing to comply with all study procedures and capable of signing informed consent.

Exclusion Criteria:

  1. Patients with active pulmonary infection.
  2. Patients with known hypersensitivity to corticosteroids
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656916


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lara Bashoura, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00656916     History of Changes
Other Study ID Numbers: 2007-0390
First Posted: April 11, 2008    Key Record Dates
Results First Posted: April 23, 2012
Last Update Posted: April 23, 2012
Last Verified: March 2012

Keywords provided by M.D. Anderson Cancer Center:
Post-Transplant Constrictive Bronchiolitis
Bronchiolitis
Fluticasone Propionate
Inhaled Corticosteroids
Lung Condition
PTCB

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents