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CompletedNCT01748279Updated Apr 23, 2013

The Effects of Atorvastatin Treatment in COPD Patients

A Phase 4 interventional study of Atorvastatin and Formoterol in COPD, sponsored by Medical University of Bialystok. Completed at 1 site in Poland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-04-23.

Sponsored by Medical University of Bialystok · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • COPD

Keywords

  • COPD
  • Atorvastatin
  • statins
  • COPD treatment
  • microarrays
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Medical University of Bialystok is the lead sponsor of 68 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

Exclusion criteria

Exclusion criteria

  1. Pregnant or nursing (lactating) women
  2. 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.
  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).
  1. Patients contraindicated for treatment with statins 7. Patients unable to perform acceptable spirometry and lung volumes procedures.
  1. 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.
  1. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
  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.
  1. Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
  1. 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.
  1. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
  1. 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Atorvastatin

    40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.

    Drug: Atorvastatin · Drug: Formoterol

  • Placebo comparator
    Lactose tablet

    One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.

    Drug: Formoterol · Drug: Lactose tablet

Interventions

  • DrugAtorvastatin

    Also known as: Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900, Freiburg, Germany

  • DrugFormoterol

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

    Also known as: Foradil, Novartis,

  • DrugLactose tablet

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

06

What researchers measure

Primary outcomes

  1. Change in CD45+ cells expression over study period

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

    Time frame: 12 weeks

  2. Change in gene expression over study period

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

    Time frame: 12 weeks

Secondary outcomes

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

  3. Change in intimal-medial thickness over study period

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

    Time frame: 12 weeks

  4. Change in hs-CRP over study period

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

Other outcomes

  1. Change in lung volumes over study period

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

    Time frame: 12 weeks

  2. Change in FEV1 over study period

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Department of Lung Diseases and Tuberculosis, Medical University of Bialystok
    Bialystok, 15-540, Poland
08

References and documents

Publications

  • Mroz RM, Lisowski P, Tycinska A, Bierla J, Trzeciak PZ, Minarowski L, Milewski R, Lisowska A, Boros P, Sobkowicz B, Duszewska AM, Chyczewska E, Musial WJ, MacNee W. Anti-inflammatory effects of atorvastatin treatment in chronic obstructive pulmonary disease. A controlled pilot study. J Physiol Pharmacol. 2015 Feb;66(1):111-28. PubMed 25716971 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01748279
Lead sponsor
Medical University of Bialystok
Responsible party
Robert M. Mroz (Associate Professor, Medical University of Bialystok) — Principal investigator
First posted
Dec 12, 2012
Start date
Dec 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Apr 23, 2013

Study contacts

Robert M Mroz, MD
principal investigator · Medical University of Bialystok, Bialystok, Poland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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