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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Doxycycline

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical Center Alkmaar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Doxycycline 100mg daily

Placebo

Outcomes

Primary Outcome Measures

myeloperoxidase in induced sputum

Secondary Outcome Measures

MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.

Lung function (FEV1)

Symptom scores

Full Information

NCT ID

NCT00857038

First Posted

March 5, 2009

Last Updated

March 5, 2009

Sponsor

Medical Center Alkmaar

Collaborators

Leiden University Medical Center, University of Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT00857038

Brief Title

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

Official Title

Doxycycline and Airway Inflammation in COPD: A Randomised Placebo Controlled Trial Studying the Effects of Doxycycline on Airway Inflammation in Patients With Moderate and Severe Stable COPD.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Medical Center Alkmaar

Collaborators

Leiden University Medical Center, University of Amsterdam

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, Inflammation, Pulmonary Emphysema

Keywords

COPD, Inflammation, Neutrophilic, Myeloperoxidase, Doxycycline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Doxycycline 100mg daily

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

Doxycycline tablets, 100mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets 100mg

Primary Outcome Measure Information:

Title

myeloperoxidase in induced sputum

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

MMP-8, MMP-9, IL-6 levels and differential cell counts in induced sputum.

Time Frame

3 weeks

Title

Lung function (FEV1)

Time Frame

3 weeks

Title

Symptom scores

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

41 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wim G Boersma, MD

Phone

0031725482750

w.boersma@mca.nl

Facility Information:

Facility Name

Medical Center Alkmaar

City

Alkmaar

State/Province

Noord-Holland

ZIP/Postal Code

1815JD

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wim G Boersma, MD

Phone

0031725482750

w.boersma@mca.nl

12. IPD Sharing Statement

Citations:

PubMed Identifier

26616678

Citation

Prins HJ, Daniels JM, Lindeman JH, Lutter R, Boersma WG. Effects of doxycycline on local and systemic inflammation in stable COPD patients, a randomized clinical trial. Respir Med. 2016 Jan;110:46-52. doi: 10.1016/j.rmed.2015.10.009. Epub 2015 Oct 30.

Results Reference

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

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