Trial Outcomes & Findings for Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease (NCT NCT00495586)

Results Overview

Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

318 participants

Primary outcome timeframe

Day 9-11

Results posted on

2012-03-13

Participant Flow

353 patients invited to participate in this trial, 32 did not fulfill the inclusion criteria (14 presented a forced expiratory volume in one second \[FEV1\]/forced vital capacity \[FVC\] ratio \> 70% and 18 a FEV1\<50%). Three more had a positive X-ray for pneumonia and were therefore excluded.

Participant milestones

Participant milestones
Measure	Placebo Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid Amoxycillin and clavulanate t.i.d. for 8 days
Overall Study STARTED	156	162
Overall Study COMPLETED	152	158
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid Amoxycillin and clavulanate t.i.d. for 8 days
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

Effectiveness of Antibiotic Therapy for Exacerbations of Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=156 Participants Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid n=162 Participants Amoxycillin and clavulanate t.i.d. for 8 days	Total n=318 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	54 Participants n=5 Participants	46 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	102 Participants n=5 Participants	116 Participants n=7 Participants	218 Participants n=5 Participants
Age Continuous	67.8 years STANDARD_DEVIATION 11.0 • n=5 Participants	68.4 years STANDARD_DEVIATION 9.9 • n=7 Participants	68.1 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	135 Participants n=7 Participants	257 Participants n=5 Participants
Region of Enrollment Spain	156 participants n=5 Participants	162 participants n=7 Participants	318 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 9-11

Population: Clinical cure at end of therapy visit at day 9-11 in the ITT population

Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability

Outcome measures

Outcome measures
Measure	Placebo n=152 Participants Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid n=158 Participants Amoxycillin and clavulanate t.i.d. for 8 days
Number of Patients Who Were Cured	91 Participants	117 Participants

SECONDARY outcome

Timeframe: One year

Population: Patients with clinical success at the end of therapy visit

For the assessment of the time till next exacerbation patients were monitored over a period of 365 days on a three-monthly basis. Patients were instructed to contact their physician immediately if there was any change in their health status. Diagnosis of a new exacerbation was based on the same clinical criteria described previously. For the calculation of time to the next exacerbation, all clinical failures occurring during therapy were counted as zero exacerbation-free interval days.

Outcome measures

Outcome measures
Measure	Placebo n=143 Participants Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid n=90 Participants Amoxycillin and clavulanate t.i.d. for 8 days
Number of Days Till the Next Exacerbation	233 Days Interval 110.0 to 365.0	160 Days Interval 66.0 to 365.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Amoxycillin and Clavulanic Acid

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=152 participants at risk Placebo pills t.i.d. for 8 days	Amoxycillin and Clavulanic Acid n=158 participants at risk Amoxycillin and clavulanate t.i.d. for 8 days
Gastrointestinal disorders Gastrointestinal disturbance	5.9% 9/152 • Number of events 9 • 20 days	14.6% 23/158 • Number of events 23 • 20 days
Gastrointestinal disorders Gastrointestinal disorder	0.66% 1/152 • Number of events 1 • 20 days	0.00% 0/158 • 20 days
Skin and subcutaneous tissue disorders Rash	1.3% 2/152 • Number of events 2 • 20 days	0.00% 0/158 • 20 days

Additional Information

Carl Llor

CAMFIC

Phone: +34 3011777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place