Trial Outcomes & Findings for Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain (NCT NCT02423577)
NCT ID: NCT02423577
Last Updated: 2017-08-14
Results Overview
Percentage of Subjects Demonstrating Viral Shedding.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Day 2 to Day 10
Results posted on
2017-08-14
Participant Flow
Potential subjects were screened to determine their susceptibility to infection with the challenge strain as indicated by a serum antibody titre less than 1:10. Only subjects susceptible to the challenge strain qualified for study specific screening.
Participant milestones
| Measure |
FF-3 Dry Powder
FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation
|
Placebo
Placebo: Placebo dry powder administered by nasal inhalation
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
26
|
|
Overall Study
COMPLETED
|
53
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain
Baseline characteristics by cohort
| Measure |
FF-3 Dry Powder
n=53 Participants
FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation
|
Placebo
n=26 Participants
Placebo: Placebo dry powder administered by nasal inhalation
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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 Kingdom
|
53 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
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
|
53 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
72 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2 to Day 10Population: The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons's method)
Percentage of Subjects Demonstrating Viral Shedding.
Outcome measures
| Measure |
FF-3 Dry Powder
n=53 Participants
FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation
|
Placebo
n=26 Participants
Placebo: Placebo dry powder administered by nasal inhalation
|
|---|---|---|
|
Frequencies of Viral Shedding
|
51 Participants
|
22 Participants
|
Adverse Events
FF-3 Dry Powder
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FF-3 Dry Powder
n=53 participants at risk
FF-3
FF-3 dry powder: FF-3 dry powder administered by nasal inhalation
|
Placebo
n=26 participants at risk
Placebo: Placebo dry powder administered by nasal inhalation
|
|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
1.9%
1/53 • Number of events 2
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
5/53 • Number of events 5
|
23.1%
6/26 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.4%
5/53 • Number of events 6
|
26.9%
7/26 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.4%
5/53 • Number of events 5
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
3.8%
2/53 • Number of events 2
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/53 • Number of events 2
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/53 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/53
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Lethargy
|
3.8%
2/53 • Number of events 2
|
0.00%
0/26
|
|
Nervous system disorders
Headache
|
9.4%
5/53 • Number of events 5
|
3.8%
1/26 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
1.9%
1/53 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Restless Legs Syndrome
|
0.00%
0/53
|
3.8%
1/26 • Number of events 1
|
|
Eye disorders
Eye pain
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Influenza Like Illness
|
64.2%
34/53 • Number of events 36
|
53.8%
14/26 • Number of events 14
|
|
General disorders
Vessel Puncture Site Haematoma
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Fatigue
|
1.9%
1/53 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Medical device site rash
|
0.00%
0/53
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Feeling Hot
|
0.00%
0/53
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Nausea
|
3.8%
2/53 • Number of events 2
|
11.5%
3/26 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
2/53 • Number of events 2
|
0.00%
0/26
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/53 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/53
|
3.8%
1/26 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Paraesthesia
|
0.00%
0/53
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Otitis Media
|
1.9%
1/53 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/53
|
3.8%
1/26 • Number of events 1
|
Additional Information
Russell Wilson, PhD
President and Chief Scientific Officer
Phone: 504-896-2789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place