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Completed

NCT Number: NCT01748279

The Effects of Atorvastatin Treatment in COPD Patients

Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients possibly as a result of an anti-inflammatory effect.

Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD.

A controlled, parallel group study to compare the effects of Atorvastatin in comparison to placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD, serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB specimens will be processed for histology, immunohistochemistry and microarray analysis.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Lung Diseases and Tuberculosis, Medical University of Bialystok

Bialystok, 15-540, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

. Written informed consent must be obtained before any assessment is performed. 2. Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.

  • Patients with moderate to very severe stable COPD (Stage II-IV) according to the GOLD guidelines.
  • Patients with a post-bronchodilator FEV1 < 80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 1.
  • Current or ex-smokers who have a smoking history of at least 10 pack years

Exclusion criteria

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment. 5. 3. Patients with a clinically significant abnormality at Visit 1.
  • Patients with a clinically relevant laboratory abnormality at Visit 1 5. Patients with a history of malignancy of any organ system (including lung cancer).
  • Patients contraindicated for treatment with statins 7. Patients unable to perform acceptable spirometry and lung volumes procedures.
  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
  • Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
  • Patients requiring oxygen therapy (>15 hr/day) on a daily basis for chronic hypoxemia 11. Patients with any history of asthma or onset of symptoms prior to age 40 years.
  • Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
  • Patients with primary bronchiectasis. 14. Patients with a diagnosis of α-1 anti-trypsin deficiency. 15. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
  • Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
  • Patients receiving any medications in the class listed in Table 5.1 18. Use of other investigational drugs within 30 days prior to visit 1.

Treatment and study plan

atorvastatin

Drug

Other names: Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900, Freiburg, Germany

Formoterol

Drug

12mcg of Foradil BID as maintenance COPD treatment in both treatment arms

Other names: Foradil, Novartis,

lactose tablet

Drug

One lactose tablet taken once a day as add-on treatment to Formoterol therapy

Primary outcomes

  1. Change in CD45+ cells expression over study period

    Time frame: 12 weeks

    Change in CD45+ cells expression measured by immunohistochemistry in lung biopsy samples assessed before and after 12 weeks of treatment

  2. Change in gene expression over study period

    Time frame: 12 weeks

    Change in gene expression measured in lung biopsy samples measured using microarrays before and after 12 weeks of treatment

Secondary outcomes

  1. Change in health related quality of life over study period

    Time frame: 12 weeks

    Change in health related quality of life assessed by St. George's respiratory questionnaire before and after 12 weeks of treatment

  2. Change in 6-Minute Walk Distance over study period

    Time frame: 12 weeks

    Change in 6-Minute Walk Distance measured according to 6-MWD protocol before and after 12 weeks of treatment

  3. Change in intimal-medial thickness over study period

    Time frame: 12 weeks

    Change in intimal-medial thickness (IMT) measured in the common carotid artery (CCA) using a standard technique.

  4. Change in hs-CRP over study period

    Time frame: 12 weeks

    Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy

  5. Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period

    Time frame: 12 weeks

    Change in total cholesterol, LDL and HDL-Cholesterol, and triglycerides measured before an after 12 weeks of therapy.

Other outcomes

  1. Change in lung volumes over study period

    Time frame: 12 weeks

    Change in lung volumes measured using body plethysmography before and after 12 weeks of treatment

  2. Change in FEV1 over study period

    Time frame: 12 weeks

    Change in FEV1 measured using spirometry before and after 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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