Inhaled Corticosteroids Versus Observation for Patients With Decreased Lung Function Status - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00656916

Purpose

Primary objective:

-To compare the lung function non deterioration rate defined by change of forced expiratory volume in one second (FEV1) of < 10% in a group of patients with evidence of early development of post-transplant constrictive bronchiolitis (PTCB) during the post engraftment period after allogeneic hematopoietic stem cell transplant, randomly assigned to receive inhaled steroids or to continue with standard of care.

Secondary objectives:

To compare the distance walked in meters during a 6 minute walk test (6MWT) in this patient population.
To compare the dyspnea scores measured using a St. George's respiratory questionnaire (SGRQ) in this patient population.
To compare the FEV1 six months and one year after study, in this patient population.
To compare the number of rescue inhaler doses used per week, in this patient population.
To compare exhaled nitric oxide level in this patient population.

Condition	Intervention	Phase
Bronchiolitis	Drug: Fluticasone Propionate Other: Observation	Phase II

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate Calcium polystyrene sulfonate Polystyrene sulfonic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To compare lung function of patients who inhale steroids in the early stages of PTCB to patients who continue with standard of care. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2008
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fluticasone Propionate	Drug: Fluticasone Propionate 440 micrograms twice daily by oral inhalation.
2: No Intervention Observation	Other: Observation No study drug, but the patient will be monitored closely. If the lung condition gets worse, the study drug will be started right away.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients >/=18 years of age.
Patients must be engrafted and 80-120 days post allogeneic hematopoietic stem cell transplantation.
New onset airflow obstruction defined as decline of FEV1 percent predicted >15%.
TLC > 85% to rule out restrictive lung disease.
Patient must be willing to comply with all study procedures and capable of signing informed consent.

Exclusion Criteria:

Patients with active pulmonary infection.
Patients who meet NIH consensus diagnosis of bronchiolitis obliterans: (a) evidence of new airflow obstruction on pulmonary function tests (PFT's) with an FEV1/FVC < 0.7 and FEV1 < 75% of predicted; (b) evidence of air trapping or small airway thickening or bronchiectasis on high resolution CT (HRCT) of the chest with inspiratory and expiratory cuts; (c) residual volume on PFT's > 120% predicted or pathological confirmation of constrictive bronchiolitis.
Patients with known hypersensitivity to corticosteroids
Patients receiving systemic steroids for treatment of PTCB (systemic steroids for other cGVHD is allowed).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656916

Contacts

Contact: Lara Bashoura, MD

713-563-0620

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Lara Bashoura, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Lara Bashoura, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Lara Bashoura, MD/Assistant Professor )
Study ID Numbers:	2007-0390
Study First Received:	April 7, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00656916
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Post-Transplant Constrictive Bronchiolitis
Bronchiolitis
Fluticasone Propionate

Inhaled Corticosteroids
Lung Condition
PTCB

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Insufficiency
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Bronchiolitis
Respiration Disorders
Fluticasone
Bronchitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs

Anti-Asthmatic Agents
Anti-Allergic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009