Trial Outcomes & Findings for Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients (NCT NCT01112059)

NCT ID: NCT01112059

Last Updated: 2017-03-06

Results Overview

Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 1 month from enrollment
• Results posted on: 2017-03-06

Participant Flow

Participant milestones

Measure	Placebo placebo: placebo	Doxycycline Doxycycline: 100 mg twice a day for 8 days
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Placebo placebo: placebo	Doxycycline Doxycycline: 100 mg twice a day for 8 days
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients

Baseline characteristics by cohort

Measure	Placebo n=19 Participants placebo: placebo	Doxycycline n=20 Participants Doxycycline: 100 mg twice a day for 8 days	Total n=39 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	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	27.3 years STANDARD_DEVIATION 9.4 • n=5 Participants	29.1 years STANDARD_DEVIATION 8.9 • n=7 Participants	28.2 years STANDARD_DEVIATION 9.1 • n=5 Participants
Gender Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Gender Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month from enrollment

Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)

Outcome measures

Measure	Placebo n=19 Participants placebo: placebo No SAEs noted in this group, 4 total AEs recorded.	Doxycycline n=20 Participants Doxycycline: 100 mg twice a day for 8 days
Number of Adverse Events	5 adverse events	5 adverse events

PRIMARY outcome

Timeframe: 8 days past baseline

Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy

Outcome measures

Measure	Placebo n=20 Participants placebo: placebo No SAEs noted in this group, 4 total AEs recorded.	Doxycycline n=19 Participants Doxycycline: 100 mg twice a day for 8 days
Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum	4034 ng/mg total protein Standard Deviation 3459	8837 ng/mg total protein Standard Deviation 14752

SECONDARY outcome

Timeframe: 8 days

Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum

Outcome measures

Measure	Placebo n=19 Participants placebo: placebo No SAEs noted in this group, 4 total AEs recorded.	Doxycycline n=20 Participants Doxycycline: 100 mg twice a day for 8 days
Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment	12683 ng/mg total protein Standard Deviation 35275	3224 ng/mg total protein Standard Deviation 2683

SECONDARY outcome

Timeframe: Baseline to end of inpatient clinical exacerbation (average 14 days)

Observe change in FEV1% predicted from beginning to end of study

Outcome measures

Measure	Placebo n=19 Participants placebo: placebo No SAEs noted in this group, 4 total AEs recorded.	Doxycycline n=20 Participants Doxycycline: 100 mg twice a day for 8 days
Mean Change in Pulmonary Function Over Treatment Duration	6.9 Percentage of predicted FEV1 Standard Deviation 10.4	10.0 Percentage of predicted FEV1 Standard Deviation 6.8

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Doxycycline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=19 participants at risk placebo: placebo	Doxycycline n=20 participants at risk Doxycycline: 100 mg twice a day for 8 days
Renal and urinary disorders Kidney stone	5.3% 1/19 • Number of events 1 • 13 months	0.00% 0/20 • 13 months
Gastrointestinal disorders Abdominal pain	10.5% 2/19 • Number of events 2 • 13 months	10.0% 2/20 • Number of events 2 • 13 months
Respiratory, thoracic and mediastinal disorders Increased cough	5.3% 1/19 • Number of events 1 • 13 months	0.00% 0/20 • 13 months
General disorders tingling of lips	0.00% 0/19 • 13 months	5.0% 1/20 • Number of events 1 • 13 months
General disorders Headache	0.00% 0/19 • 13 months	5.0% 1/20 • Number of events 1 • 13 months
Renal and urinary disorders Pelvic pain	5.3% 1/19 • Number of events 1 • 13 months	0.00% 0/20 • 13 months
Gastrointestinal disorders Nausea	0.00% 0/19 • 13 months	5.0% 1/20 • Number of events 1 • 13 months

Additional Information

Amit Gaggar, MD

UAB

Phone: 934-5400

Email: agaggar@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place