Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial. - TEXACOLD trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36745

Enrollment

2000

Registered

2010-08-20

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exacerbation COPD

Interventions

In case of an exacerbation patients will be randomized. After randomization, patients will be treated for 7 days with doxycyclin or with placebo. All patients will receive a course of oral prednison

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible for the cohort are patients aged >= 45 years, with a smoking history of > 10 packyears and GOLD stage 1, 2 or 3; i.e. a post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio 30% [30]. Patients will be included who had at least one documented episode of exacerbation during the past 3 years, with the restriction that treatment of the last exacerbation ended at least 4 week prior to inclusion in the study, and that symptoms returned to patient*s baseline level.;In case of an exacerbation, patients will be randomized between doxycyclin 100 mg daily (1st day 200 mg), for 7 days, or placebo.

Exclusion criteria

Exclusion criteria: Excluded are patients with - poor cognitive functioning, - poor mastering of the Dutch language, - allergy for doxycyclin, - pregnancy, - a life expectancy less than one month.;In case of an exacerbation, patients will be randomized between doxycyclin and placebo. Not eligible for randomization are patients • who should be treated with antibiotics according to the Dutch College of General Practitioners' guidelines for diagnosis and treatment of COPD and the Dutch multidisciplinary guideline for medical treatment of COPD (2008, NVALT/NHG): in case of symptoms of clinical infection (body temperature > 38.5C), or a low baseline expiratory flow rate (FEV1

Design outcomes

Primary

Measure	Time frame
The primary endpoint is time to the next exacerbation.	—

Secondary

Measure	Time frame
Secondary endpoints are number of exacerbations and mortality during follow-up, early and late treatment failure rates, health-related QoL, cultured microorganisms during subsequent exacerbations, total antibiotic use, decrease in lung function, and costs (economic evaluation).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)