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Trial record 27 of 43 for:    "Bronchial Disease" | "Azithromycin"

Targeted Therapy of Bronchiolitis Obliterans Syndrome (FAM for BOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01307462
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bronchiolitis Obliterans
Interventions Drug: fluticasone propionate
Drug: montelukast sodium
Drug: azithromycin
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 36
Completed 35
Not Completed 1
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants
57
(24 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
17
  47.2%
Male
19
  52.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Hispanic or Latino
1
   2.8%
Not Hispanic or Latino
35
  97.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   5.6%
White
34
  94.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Subjects Who Failed Treatment
Hide Description Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.
Time Frame Within 3 months after initiation of study medications
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
2
   5.6%
2.Secondary Outcome
Title Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result
Hide Description National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0)
Time Frame From baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs attributable to FAM
11
  30.6%
Stopped FAM during study
1
   2.8%
3.Secondary Outcome
Title Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO
Hide Description [Not Specified]
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone)
Hide Description [Not Specified]
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Subjects With Improvements in Other Chronic GVHD Characteristics
Hide Description Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
33 of 36 participants were evaluable at 3 months due to missing provider survey data
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
12
  36.4%
6.Secondary Outcome
Title Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%
Hide Description [Not Specified]
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
24 out of 36 subjects were evaluable at 6mo due to missing data.
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
17
  70.8%
7.Secondary Outcome
Title Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
Hide Description SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
24 of 36 subjects were evaluable at 6mo due to missing patient survey data.
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: units on a scale
SF-36 norm-based physical functioning score
0.0
(-23.15 to 14.73)
SF-36 norm-based role-physical score
0.0
(-17.14 to 39.18)
SF-36 norm-based bodily pain score
0.0
(-13.52 to 17.33)
SF-36 norm-based general health score
-2.38
(-20.02 to 17.64)
SF-36 norm-based vitality score
1.56
(-15.61 to 21.85)
SF-36 norm-based social functioning score
5.45
(-27.27 to 38.18)
SF-36 norm-based role-emotional score
0.0
(-23.32 to 23.32)
SF-36 norm-based mental health score
0.0
(-11.26 to 16.9)
SF-36 standardized physical component score
-1.21
(-21.65 to 25.16)
SF-36 standardized mental component score
1.64
(-21.63 to 25.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based physical functioning score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .81
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based role-physical score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based bodily pain score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .48
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based general health score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .26
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based vitality score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based social functioning score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based role-emotional score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 norm-based mental health score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 standardized physical component score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .80
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments SF-36 standardized mental component score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .23
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
Hide Description

FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.

FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
24 of 36 subjects were evaluable at 6mo due to missing patient survey data.
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: units on a scale
FACT physical well-being
0.5
(-8 to 12)
FACT social/family well-being
-1
(-6.83 to 7)
FACT emotional well-being
0
(-6 to 17)
FACT functional well-being
1
(-15 to 13)
FACT BMT subscale
-0.78
(-7 to 10)
FACT trial outcome index
2
(-30 to 22)
FACT-G
2.5
(-23 to 23.67)
FACT-BMT total
2.17
(-30 to 25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT physical well-being
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT social/family well-being
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT emotional well-being
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT functional well-being
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT BMT subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .84
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT trial outcome index
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT-G
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .71
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments FACT-BMT total
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
Hide Description

HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.

Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.

Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.

Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78.

Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
24 of 36 subjects were evaluable at 6mo due to missing patient survey data.
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: units on a scale
HAP MAS
0.5
(-41 to 30)
HAP AAS
4.5
(-49 to 42)
Modified HAP AAS
3.5
(-46 to 36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments HAP maximum activity score - highest item still doing
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .37
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments HAP adjusted activity score - MAS minus stopped
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .39
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Modified HAP adjusted activity score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .39
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
Hide Description Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
24 of 36 subjects were evaluable at 6mo due to missing patient survey data.
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description:
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: units on a scale
LSS skin scale
-5.63
(-45 to 50)
LSS energy scale
-7.14
(-39.29 to 14.29)
LSS lung scale
-5
(-55 to 45)
LSS eye scale
-8.33
(-66.67 to 8.33)
LSS nutrition scale
0
(-30 to 10)
LSS psychological scale
0
(-50 to 50)
LSS mouth scale
0
(-75 to 0)
LSS overall summary scale
-7.77
(-32.21 to 2.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom skin scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom energy scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom lung scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .20
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom eye scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom nutrition scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom psychological scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .22
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom mouth scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Treatment (BOS Therapy)
Comments Lee symptom overall summary scale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (BOS Therapy)
Hide Arm/Group Description Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (BOS Therapy)
Affected / at Risk (%)
Total   1/36 (2.78%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (BOS Therapy)
Affected / at Risk (%) # Events
Total   24/36 (66.67%)    
Blood and lymphatic system disorders   
Neutropenia  1  1/36 (2.78%)  1
Leukocytosis  1  1/36 (2.78%)  1
General disorders   
Edema limbs  1  1/36 (2.78%)  1
Fever  1  1/36 (2.78%)  1
Infections and infestations   
Sepsis  1  1/36 (2.78%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  2/36 (5.56%)  2
Musculoskeletal and connective tissue disorders   
Pain  1  2/36 (5.56%)  2
Nervous system disorders   
Presyncope  1  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary nodules  1  1/36 (2.78%)  1
Hypoxia  1  1/36 (2.78%)  1
Pneumonia  1  3/36 (8.33%)  3
Pneumonitis  1  1/36 (2.78%)  1
Fluid overload  1  1/36 (2.78%)  1
Lung infection  1  3/36 (8.33%)  3
Dyspnea  1  3/36 (8.33%)  4
Pulmonary Embolus  1  1/36 (2.78%)  1
1
Term from vocabulary, SNOMED CT
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (BOS Therapy)
Affected / at Risk (%) # Events
Total   9/36 (25.00%)    
Cardiac disorders   
Ventricular tachycardia  1  1/36 (2.78%)  1
General disorders   
Edema  1  1/36 (2.78%)  1
Investigations   
Alanine aminotransferase increased  1  1/36 (2.78%)  1
Thrombocytopenia  1  1/36 (2.78%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders   
Cavitary Pulmonary Lesion  1  1/36 (2.78%)  1
Lung infection  1  1/36 (2.78%)  1
Skin and subcutaneous tissue disorders   
Rash maculopapular  1  1/36 (2.78%)  1
Vascular disorders   
Hypertension  1  1/36 (2.78%)  1
1
Term from vocabulary, SNOMED CT
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guang-Shing Cheng MD
Organization: FHCRC
Phone: 206-667-7074
Responsible Party: Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01307462     History of Changes
Other Study ID Numbers: 2367.00
NCI-2011-00203 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U54CA163438 ( U.S. NIH Grant/Contract )
RDCRN 6503 ( Other Identifier: DMCC )
First Submitted: March 1, 2011
First Posted: March 3, 2011
Results First Submitted: January 20, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017