Doxycycline and Airway Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

COPD is a progressive pulmonary disease that is characterized by an inflammatory process in the airways and the lungs which leads to progressive airway obstruction. The inflammation is associated with tissue loss and remodelling. The investigators hypothesized that doxycycline reduces neutrophilic airway inflammation in patients with COPD. Therefore the investigators will conduct a randomized trial of doxycycline in 30 patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific

NCT03151395

Respiratory Disorders

COMPLETED NA

Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath

NCT00442468

Pulmonary Disease, Chronic Obstructive

COMPLETED

Systemic Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

NCT00850863

Chronic Obstructive Pulmonary Disease

UNKNOWN

The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)

NCT03956888

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE3

A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects

NCT00848406

Asthma Copd

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Rationale:

COPD is a disease characterized by chronic inflammation and irreversible airway obstruction. Chronic inflammation lead to degradation of extracellular matrix and hereby destruction of lung parenchyma. Tetracyclines are known for their anti-inflammatory properties in diseases such as rheumatoid arthritis.

Objective:

To assess the effect of doxycycline on markers of neutrophilic inflammation and proteolytic activity in induced sputum of stable GOLD II and III COPD patients.

Study population:

Thirty patients with stable GOLD II COPD.

Intervention:

Placebo versus doxycycline in randomised design.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Inflammation Pulmonary Emphysema

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Doxycycline 100mg daily

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Doxycycline tablets, 100mg daily

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets 100mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxycycline

Doxycycline tablets, 100mg daily

Intervention Type DRUG

Placebo

Placebo tablets 100mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* GOLD II or III COPD (GOLD II: FEV1/FVC \< 70%; 50% \< FEV1 \< 80% predicted, GOLD III: FEV1/FVC \< 70%; 30% \< FEV1 \< 50% predicted ).
* Stable disease (no exacerbations in the last 3 months).
* Age \> 40 yrs.
* Written informed consent.

Exclusion Criteria

* Infections and/or use of antibiotics in the last month.
* Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
* Allergy for tetracyclines or a history of substantial side-effects.
* Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
* Acute exacerbation of COPD as defined by Anthonisen et al. \[10\].
* Signs and/or symptoms of a current respiratory or non-respiratory infection.
* Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.

Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No