Trial Outcomes & Findings for Targeted Retreatment of COPD Exacerbations (NCT NCT02300220)
NCT ID: NCT02300220
Last Updated: 2021-03-08
Results Overview
The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Up to 90 days
Results posted on
2021-03-08
Participant Flow
Participant milestones
| Measure |
Ciproflaxacin
Retreatment with Ciproflaxacin
|
Placebo
Retreatment with Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
COMPLETED
|
68
|
65
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
Ciproflaxacin
Retreatment with Ciproflaxacin
|
Placebo
Retreatment with Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Did not tolerate IMP
|
0
|
1
|
Baseline Characteristics
Targeted Retreatment of COPD Exacerbations
Baseline characteristics by cohort
| Measure |
Ciprofloxacin
n=72 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=72 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
69.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 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)
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
|
69 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
138 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
72 participants
n=5 Participants
|
72 participants
n=7 Participants
|
144 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 90 daysThe primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
Outcome measures
| Measure |
Ciprofloxacin
n=72 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=72 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Time to the Next COPD Exacerbation
|
72 days
Interval 29.0 to 90.0
|
58 days
Interval 24.5 to 90.0
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Missing participants data 16 for ciprofloxacin and 15 for placebo
Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.
Outcome measures
| Measure |
Ciprofloxacin
n=56 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=57 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Duration of the Initial Exacerbation
|
3 days
Interval 0.0 to 8.0
|
4 days
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 7 days of treatmentSecondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
Outcome measures
| Measure |
Ciprofloxacin
n=72 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=72 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Number of Participants With Serious Non Fatal Adverse Events
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and 90 daysPopulation: Only the participants who completed the study
Secondary endpoints will include changes from randomization to 90 days in FEV1.
Outcome measures
| Measure |
Ciprofloxacin
n=63 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=63 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Changes in Lung Function
|
0.0229 litres
Standard Deviation 0.199
|
0.0041 litres
Standard Deviation 0.198
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Lower participants number due to the number of patients with a pathogenic organism with newly acquired ciprofloxacin resistance, present in a sputum sample collected at 90 days
Bacterial load and resistance Secondary endpoints will include resistance following targeted retreatment with the IMP or placebo.
Outcome measures
| Measure |
Ciprofloxacin
n=16 Participants
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=17 Participants
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Number of Participants Who Have Resistance Bacteria in the Sputum
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 days of treatmentPopulation: Data not collected
Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.
Outcome measures
Outcome data not reported
Adverse Events
Ciprofloxacin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Placebo
Serious events: 9 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ciprofloxacin
n=72 participants at risk
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=72 participants at risk
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncology
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/72 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/72 • 90 days + 1 month
|
2.8%
2/72 • Number of events 2 • 90 days + 1 month
|
|
Psychiatric disorders
Psychological
|
0.00%
0/72 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
0.00%
0/72 • 90 days + 1 month
|
5.6%
4/72 • Number of events 4 • 90 days + 1 month
|
Other adverse events
| Measure |
Ciprofloxacin
n=72 participants at risk
500 mg, twice daily for 1 week (oral).
Ciprofloxacin: 500 mg, twice daily for 1 week (oral)
|
Placebo
n=72 participants at risk
one capsule, twice daily for 1 week.
Placebo: One capsule, twice daily for 1 week
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/72 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
5/72 • Number of events 5 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
0.00%
0/72 • 90 days + 1 month
|
|
Gastrointestinal disorders
Abdominal Colic/Pain
|
2.8%
2/72 • Number of events 2 • 90 days + 1 month
|
2.8%
2/72 • Number of events 2 • 90 days + 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritis/Rash
|
0.00%
0/72 • 90 days + 1 month
|
2.8%
2/72 • Number of events 2 • 90 days + 1 month
|
|
Nervous system disorders
Dry Mouth
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
0.00%
0/72 • 90 days + 1 month
|
|
Musculoskeletal and connective tissue disorders
Ankle Pain/Tendonitis
|
2.8%
2/72 • Number of events 2 • 90 days + 1 month
|
0.00%
0/72 • 90 days + 1 month
|
|
Nervous system disorders
Tremor
|
0.00%
0/72 • 90 days + 1 month
|
1.4%
1/72 • Number of events 1 • 90 days + 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place