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

M

Medical Center Alkmaar

Status and phase

Unknown
Phase 4

Conditions

Inflammation
Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease

Treatments

Drug: Doxycycline
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00857038
M07-046

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

41+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Doxycycline 100mg daily
Treatment:
Drug: Doxycycline
2
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Wim G Boersma, MD

Data sourced from clinicaltrials.gov

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