Trial Outcomes & Findings for Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients (NCT NCT02351180)
NCT ID: NCT02351180
Last Updated: 2022-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
16 participants
Primary outcome timeframe
180 days
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Inhaled Beclomethasone
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Inhaled Beclomethasone
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients
Baseline characteristics by cohort
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 20.7 • n=99 Participants
|
62 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
57.1 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Bronchiolitis Obliterans Syndrome Stage
BOS Stage 0 or 0p (Forced expiratory volume in 1 second is at least 81% of baseline)
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Bronchiolitis Obliterans Syndrome Stage
BOS Stage 1 or 2 (Forced expiratory volume in 1 second is between 51-80% of baseline)
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Acute Rejection
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Lymphocytic Bronchiolitis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Donor-specific Antibodies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Inhaled Beclomethasone
n=7 Participants
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=7 Participants
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Chronic Lung Allograft Dysfunction
|
2 Participants
|
3 Participants
|
Adverse Events
Inhaled Beclomethasone
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Beclomethasone
n=7 participants at risk
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 participants at risk
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Lung Allograft Dysfunction
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
New Respiratory Viral Infection
|
28.6%
2/7 • Number of events 2 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Infection
|
0.00%
0/7 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Nervous system disorders
Stroke
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Hepatobiliary disorders
Cholecystitis
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
Other adverse events
| Measure |
Inhaled Beclomethasone
n=7 participants at risk
Inhaled beclomethasone 320 mcg twice daily for 180 days.
Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
|
Placebo
n=8 participants at risk
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
New Respiratory Viral Infection
|
85.7%
6/7 • Number of events 7 • 180 days
|
37.5%
3/8 • Number of events 3 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
|
General disorders
Cold Symptoms
|
14.3%
1/7 • Number of events 1 • 180 days
|
50.0%
4/8 • Number of events 4 • 180 days
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
14.3%
1/7 • Number of events 1 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
General disorders
Hoarseness
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Endocrine disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
General disorders
Fatigue
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Skin and subcutaneous tissue disorders
Skin Cancer
|
14.3%
1/7 • Number of events 2 • 180 days
|
0.00%
0/8 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2 • 180 days
|
25.0%
2/8 • Number of events 2 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Lung Allograft Dysfunction
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
|
Infections and infestations
Mycobacterial Infection
|
0.00%
0/7 • 180 days
|
12.5%
1/8 • Number of events 1 • 180 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
|
Infections and infestations
Oral Candidiasis
|
14.3%
1/7 • Number of events 1 • 180 days
|
0.00%
0/8 • 180 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place