Trial Outcomes & Findings for CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) (NCT NCT04684641)
NCT ID: NCT04684641
Last Updated: 2023-11-18
Results Overview
Change in sputum bacterial culture titers of Pseudomonas as measured by colony forming units/mL at day 14
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Day 14
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Phage Therapy
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CYstic Fibrosis bacterioPHage Study at Yale (CYPHY)
Baseline characteristics by cohort
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
50.50 Years
STANDARD_DEVIATION 24.96 • n=5 Participants
|
49.50 Years
STANDARD_DEVIATION 18.27 • n=7 Participants
|
50.00 Years
STANDARD_DEVIATION 20.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Change in sputum bacterial culture titers of Pseudomonas as measured by colony forming units/mL at day 14
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Change in Sputum Bacterial Culture
|
-0.59 CFU/mL
Standard Deviation 1.62
|
-0.89 CFU/mL
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Screening, day 14, day 21, day 28, and day 56Change in lung function \[percent predicted forced expiratory volume in 1 second (FEV1pp)\] in subjects randomized to phage therapy and placebo from screening to day 14, 21, 28, and 56
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Change in Lung Function
Change in FEV1pp from Screening to Day 14
|
-1.25 FEV1pp
Standard Deviation 4.65
|
0.50 FEV1pp
Standard Deviation 1.29
|
|
Change in Lung Function
Change in FEV1pp from Screening to Day 21
|
-3.25 FEV1pp
Standard Deviation 3.50
|
0.00 FEV1pp
Standard Deviation 4.36
|
|
Change in Lung Function
Change in FEV1pp from Screening to Day 28
|
-1.50 FEV1pp
Standard Deviation 4.20
|
0.25 FEV1pp
Standard Deviation 4.11
|
|
Change in Lung Function
Change in FEV1pp from Screening to Day 56
|
-1.00 FEV1pp
Standard Deviation 2.65
|
-1.00 FEV1pp
Standard Deviation 9.90
|
SECONDARY outcome
Timeframe: Baseline, day 56Compare the rates of pulmonary exacerbations between subjects randomized to phage therapy versus placebo during the first 56 days of the study
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Difference in the Rate of Pulmonary Exacerbations
|
1 Count of Pulmonary Exacerbation(s)
|
1 Count of Pulmonary Exacerbation(s)
|
SECONDARY outcome
Timeframe: Baseline, day 56Compare the rates of hospitalizations between subjects randomized to phage therapy versus placebo during the first 56 days of the study
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Difference in the Rate of Hospitalization
|
0 Count of Hospitalization(s)
|
1 Count of Hospitalization(s)
|
SECONDARY outcome
Timeframe: Baseline, day 56Compare the rates of acute antibiotic use between subjects randomized to phage therapy versus placebo during the first 56 days of the study
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Difference in the Rate of Acute Antibiotic Use
|
1 Instance(s) of acute antibiotic use
|
1 Instance(s) of acute antibiotic use
|
SECONDARY outcome
Timeframe: Baseline, day 56Changes in subject-reported quality of life, using the Cystic Fibrosis Questionnaire Revised (CFQ-R) Teen/Adult, from baseline to Day 56. This survey consists of 50 questions that relate to a subjects clinical condition and mental health. Scores for each domain range from 0 to 100, with higher scores indicating a higher patient-reported quality of life with regard to the domain being evaluated.
Outcome measures
| Measure |
Phage Therapy
n=4 Participants
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 Participants
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Patient's Quality of Life
Emotion
|
-8.33 Change in CFQR score from baseline
Standard Deviation 3.33
|
-10.00 Change in CFQR score from baseline
Standard Deviation 20.00
|
|
Patient's Quality of Life
Treatment Burden
|
-2.78 Change in CFQR score from baseline
Standard Deviation 16.67
|
-8.33 Change in CFQR score from baseline
Standard Deviation 31.91
|
|
Patient's Quality of Life
Health Perceptions
|
-8.33 Change in CFQR score from baseline
Standard Deviation 5.56
|
11.11 Change in CFQR score from baseline
Standard Deviation 24.00
|
|
Patient's Quality of Life
Role
|
-8.33 Change in CFQR score from baseline
Standard Deviation 11.79
|
-4.17 Change in CFQR score from baseline
Standard Deviation 4.81
|
|
Patient's Quality of Life
Weight
|
0.00 Change in CFQR score from baseline
Standard Deviation 0.00
|
0.00 Change in CFQR score from baseline
Standard Deviation 0.00
|
|
Patient's Quality of Life
Respiratory
|
-5.56 Change in CFQR score from baseline
Standard Deviation 16.36
|
-4.17 Change in CFQR score from baseline
Standard Deviation 13.89
|
|
Patient's Quality of Life
Physical
|
-6.25 Change in CFQR score from baseline
Standard Deviation 12.95
|
0.00 Change in CFQR score from baseline
Standard Deviation 22.82
|
|
Patient's Quality of Life
Vitality
|
-12.50 Change in CFQR score from baseline
Standard Deviation 17.35
|
-2.08 Change in CFQR score from baseline
Standard Deviation 21.92
|
|
Patient's Quality of Life
Eat
|
2.78 Change in CFQR score from baseline
Standard Deviation 5.56
|
-16.67 Change in CFQR score from baseline
Standard Deviation 26.45
|
|
Patient's Quality of Life
Social
|
1.39 Change in CFQR score from baseline
Standard Deviation 9.49
|
-2.78 Change in CFQR score from baseline
Standard Deviation 7.17
|
|
Patient's Quality of Life
Body
|
0.00 Change in CFQR score from baseline
Standard Deviation 9.07
|
0.00 Change in CFQR score from baseline
Standard Deviation 0.00
|
|
Patient's Quality of Life
Digestion
|
0.00 Change in CFQR score from baseline
Standard Deviation 0
|
-8.33 Change in CFQR score from baseline
Standard Deviation 16.66666667
|
Adverse Events
Phage Therapy
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phage Therapy
n=4 participants at risk
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 participants at risk
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
CF-Related Pulmonary Exacerbation
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
Other adverse events
| Measure |
Phage Therapy
n=4 participants at risk
Participants will be randomized to receive 3mL phage therapy, nebulized daily for 7 days.
Standard Dose YPT-01: Participants will be randomized to receive the standard dose of phage therapy YPT-01.
|
Placebo
n=4 participants at risk
Participants will be randomized to receive the 3mL placebo, nebulized daily for 7 days.
Placebo: Participants will be randomized to receive the placebo.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
25.0%
1/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Nervous system disorders
Blurred vision
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Musculoskeletal and connective tissue disorders
Bruised Toe
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Bruising and swelling at blood draw site
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
CF-Related Pulmonary Exacerbation
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
50.0%
2/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 Positive
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Dizziness
|
50.0%
2/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Epistaxis
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
75.0%
3/4 • Number of events 3 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Feeling Cold
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Flushing
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
75.0%
3/4 • Number of events 3 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Headache
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
75.0%
3/4 • Number of events 3 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Hoarseness
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Increased sputum production
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Renal and urinary disorders
Kidney Stones
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Myalgia
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
50.0%
2/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
25.0%
1/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Psychiatric disorders
Nightmares
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
50.0%
2/4 • Number of events 3 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
50.0%
2/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Sweaty
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
25.0%
1/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Vomiting
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
50.0%
2/4 • Number of events 2 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
|
General disorders
Weight gain
|
25.0%
1/4 • Number of events 1 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
0.00%
0/4 • 6 months
In addition to events spontaneously reported by subjects during visits or in their AE diary, at each visit subjects will be specifically asked whether they have experienced increased sputum production, shortness of breath, hemoptysis, chest pain, cough, and fever or chills since their last visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place