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

NCT00857038 | Unknown Phase 4

• 1 other identifier: M07-046
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Inflammation; Pulmonary Emphysema

Keywords

COPD; Inflammation; Neutrophilic; Myeloperoxidase; Doxycycline

Outcome Measures

Primary Outcomes (1)

• myeloperoxidase in induced sputum

  3 weeks

Secondary Outcomes (3)

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

  3 weeks

• Lung function (FEV1)

  3 weeks

• Symptom scores

  3 weeks

Study Arms (2)

1

EXPERIMENTAL

Doxycycline 100mg daily

Drug: Doxycycline

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Doxycycline DRUG

Doxycycline tablets, 100mg daily

1

Placebo DRUG

Placebo tablets 100mg

2

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Center Alkmaar: lead
• Leiden University Medical Center: collaborator
• University of Amsterdam: collaborator

Study Sites (1)

Medical Center Alkmaar

Alkmaar, North Holland, 1815JD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26616678 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Pulmonary Emphysema

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Wim G Boersma, MD

CONTACT

0031725482750; w.boersma@mca.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 6, 2009

Record last verified: 2009-03

Locations

NL (1)