Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma (NCT NCT01720069)
NCT ID: NCT01720069
Last Updated: 2020-04-21
Results Overview
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
197 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-04-21
Participant Flow
197 subjects were randomised and 196 received at least one dose of study drug; 1 subject was randomised but not treated.
Participant milestones
| Measure |
Dose 1 VR506 50 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
71
|
63
|
|
Overall Study
Full Anaylsis Set
|
62
|
71
|
63
|
|
Overall Study
COMPLETED
|
57
|
56
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
15
|
15
|
Reasons for withdrawal
| Measure |
Dose 1 VR506 50 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Overall Study
Could not use e-diary correctly
|
0
|
1
|
1
|
|
Overall Study
Randomised without baseline values
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
0
|
|
Overall Study
Treatment period withdrawal criteria met
|
4
|
8
|
9
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
OCS bursts occured, discontinued in line
|
1
|
0
|
0
|
|
Overall Study
Non-compliance on using e-diary
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of Asthma
Baseline characteristics by cohort
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
14 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
49 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The Full Analysis Set (FAS) was analyzed, however 7 subjects are not included because they had no OCS dose adjustment assessment post-randomisation, and baseline values were not carried forward.
The mean asthma control prednisone/prednisolone dose at end of study (week 16)
Outcome measures
| Measure |
Dose 1 VR506 50 mcg
n=61 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=70 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=58 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)
|
4.55 mg
Standard Deviation 6.85
|
4.31 mg
Standard Deviation 7.38
|
3.97 mg
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksOutcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
|
0.06 Liters
Standard Deviation 0.4
|
0.02 Liters
Standard Deviation 0.31
|
0.06 Liters
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Full Analysis Set was analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose ACQ-5 assessment, baseline value was not carried forward.
Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).
Outcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=70 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score
|
-0.67 score on a scale
Standard Deviation 0.98
|
-0.77 score on a scale
Standard Deviation 1.15
|
-0.39 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksOutcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
|
2 L/min
Standard Deviation 45.7
|
20.1 L/min
Standard Deviation 51.7
|
6.1 L/min
Standard Deviation 53.5
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksTo measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).
Outcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score
|
-0.3 score on a scale
Standard Deviation 1
|
-0.6 score on a scale
Standard Deviation 1
|
-0.2 score on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Number of Participants With Withdrawals Due to Worsening of Asthma
|
4 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPercentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire
Outcome measures
| Measure |
Dose 1 VR506 50 mcg
n=62 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 Participants
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Assessment of Acceptability of the Device
Very easy
|
40 Participants
|
49 Participants
|
38 Participants
|
|
Assessment of Acceptability of the Device
Fairly easy
|
21 Participants
|
21 Participants
|
21 Participants
|
|
Assessment of Acceptability of the Device
Missing
|
1 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Dose 1 VR506 50 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Dose 2 VR506 250 mcg
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Dose 3 VR506 500 mcg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose 1 VR506 50 mcg
n=62 participants at risk
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 2 VR506 250 mcg
n=71 participants at risk
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
Dose 3 VR506 500 mcg
n=63 participants at risk
VR506 inhalation powder delivered via a new dry powder inhaler device
VR506: VR506 inhalation powder delivered via a new dry powder inhaler device
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
19.4%
12/62 • Number of events 15 • 16 weeks
|
36.6%
26/71 • Number of events 35 • 16 weeks
|
19.0%
12/63 • Number of events 16 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
2/62 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
3.2%
2/63 • Number of events 2 • 16 weeks
|
|
Nervous system disorders
Headache
|
3.2%
2/62 • Number of events 3 • 16 weeks
|
5.6%
4/71 • Number of events 4 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/62 • 16 weeks
|
2.8%
2/71 • Number of events 3 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
3.2%
2/63 • Number of events 3 • 16 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.2%
2/62 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/62 • Number of events 2 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
3.2%
2/63 • Number of events 3 • 16 weeks
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/62 • 16 weeks
|
4.2%
3/71 • Number of events 4 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Oral candidiasis
|
3.2%
2/62 • Number of events 2 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Bronchitis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Phyaryngitis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Cystisis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Ear Infection
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Oropharyngitis Fungal
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Otitis Media
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Tonsillitis Streptococcal
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Viral Pharyngitis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Nervous system disorders
Neuralgia
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Nervous system disorders
Radiculitis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Investigations
Aspartate Aminotransferase
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
1.6%
1/62 • Number of events 1 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Ear and labyrinth disorders
Middle Ear Effusion
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
General disorders
Asthenia
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/62 • 16 weeks
|
1.4%
1/71 • Number of events 1 • 16 weeks
|
0.00%
0/63 • 16 weeks
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/62 • 16 weeks
|
0.00%
0/71 • 16 weeks
|
1.6%
1/63 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Vectura's agreements with its investigators may vary. Publication may be delayed for Sponsor review and revisions/deletions can be required. Furthermore, a delay to publication may be required by the Sponsor in order to take steps to protect its proprietary information and/or intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER