Trial Outcomes & Findings for Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome (NCT NCT01287078)
NCT ID: NCT01287078
Last Updated: 2020-09-24
Results Overview
Participants who responded to treatment with cyclosporine inhalation solution (CIS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
18 weeks
Results posted on
2020-09-24
Participant Flow
Two subjects withdrew consent after signing
Participant milestones
| Measure |
Inhaled Cyclosporine in HSCT Recipients
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
3
|
|
Overall Study
COMPLETED
|
10
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
Baseline characteristics by cohort
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=20 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=3 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 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
|
20 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants who responded to treatment with cyclosporine inhalation solution (CIS)
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS)
|
9 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants who did not respond to treatment with cyclosporine inhalation solution (CIS)
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Overall Non-response to Treatment
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with stable or progressive disease at baseline with improvement of FEV1
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Stable or Progressive Disease at Baseline With Improvement of FEV1
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with progressive disease at baseline with stablization of FEV1
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Disease Progression at Baseline With Stablization of FEV1
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with stable disease at baseline with stablization in FEV1 and greater than 25% decline in systemic immunosuppression
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Disease Stability at Baseline With Stablization in FEV1 and Greater Than 25% Decline in Systemic Immunosuppression
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with stable or progressive disease at baseline with greater than 20% of decline in FEV1
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Stable or Progressive Disease at Baseline With Greater Than 20% of Decline in FEV1
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with stable disease at baseline with stablization of FEV1 and no change or increase in systemic immunosuppresion
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Stable Disease at Baseline With Stablization of FEV1 and no Change or Increase in Systemic Immunosuppresion
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 18 weeksPopulation: Subjects who received cyclosporine inhalation solution (CIS) for at least two weeks or three doses
Participants with progressive disease at baseline with decline in FEV1 greater than 10%
Outcome measures
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=16 Participants
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=2 Participants
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Disease Progression at Baseline With Decline in FEV1 Greater Than 10%
|
2 Participants
|
0 Participants
|
Adverse Events
Inhaled Cyclosporine in HSCT Recipients
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Inhaled Cyclosporine in Lung Transplant Recipients
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=20 participants at risk
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=3 participants at risk
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute myeloid leukaemia recurrent
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Enterovirus infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Rhinovirus infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Viral pericarditis
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
Other adverse events
| Measure |
Inhaled Cyclosporine in HSCT Recipients
n=20 participants at risk
Subjects who underwent Hematopoietic Stem Cell Transplant (HSCT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
Inhaled Cyclosporine in Lung Transplant Recipients
n=3 participants at risk
Subjects who underwent Lung Transplant (LT) and developed Bronchiolitis Obliterans Syndrome (BOS) received cyclosporine inhalation solution (CIS) 150 mg, three times weekly during weeks 1-5. Dose escalated to 300 mg three times weekly from weeks 6-8. Study drug administration ended at week 19.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Cardiac disorders
Chest pain
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Cardiac disorders
Dizziness
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Cardiac disorders
Dyspnoea
|
10.0%
2/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Endocrine disorders
Hypoglycaemia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
2/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
General disorders
Fatigue
|
25.0%
5/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
General disorders
Oedema
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Immune system disorders
Graft versus host disease in eye
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Immune system disorders
Graft versus host disease in skin
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Bronchitis
|
10.0%
2/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Infection
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Lung infection
|
20.0%
4/20 • 18 weeks
|
100.0%
3/3 • 18 weeks
|
|
Infections and infestations
Mycobacterium abscessus infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
3/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Investigations
Blood creatine increased
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Body temperature increased
|
15.0%
3/20 • 18 weeks
|
66.7%
2/3 • 18 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Hyperkalaemia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Investigations
Hypernatraemia
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Hypoalbuminaemia
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Investigations
Neck pain
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Investigations
Weight decreased
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
2/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Nervous system disorders
Gait disturbance
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Nervous system disorders
Restlessness
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Renal and urinary disorders
Genitourinary symptom
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
40.0%
8/20 • 18 weeks
|
66.7%
2/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
15/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
10/20 • 18 weeks
|
66.7%
2/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
4/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation decreased
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • 18 weeks
|
33.3%
1/3 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Vascular disorders
Dizziness
|
10.0%
2/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • 18 weeks
|
66.7%
2/3 • 18 weeks
|
|
Vascular disorders
Oedema
|
5.0%
1/20 • 18 weeks
|
0.00%
0/3 • 18 weeks
|
Additional Information
Dr Richard Childs
National Heart Lung and Blood Institute
Phone: 301-451-7128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place