The Effects of Atorvastatin Treatment in COPD Patients

NCT01748279 | Completed Phase 4 DMC

• 2 other identifiers: 113-46-966N N402 593440
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD; Atorvastatin; statins; COPD treatment; microarrays

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks

• 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

  12 weeks

Secondary Outcomes (5)

• Change in health related quality of life over study period

  12 weeks

• Change in 6-Minute Walk Distance over study period

  12 weeks

• Change in intimal-medial thickness over study period

  12 weeks

• Change in hs-CRP over study period

  12 weeks

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

  12 weeks

Other Outcomes (2)

• Change in lung volumes over study period

  12 weeks

• Change in FEV1 over study period

  12 weeks

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

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

Drug: Atorvastatin; Drug: Formoterol

Lactose tablet

PLACEBO COMPARATOR

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

Drug: Formoterol; Drug: Lactose tablet

Interventions

Atorvastatin DRUG

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

Atorvastatin

Formoterol DRUG

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

Also known as: Foradil, Novartis,

Atorvastatin; Lactose tablet

Lactose tablet DRUG

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

Lactose tablet

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Department of Lung Diseases and Tuberculosis, Medical University of Bialystok

Bialystok, 15-540, Poland

Location

Related Publications (1)

• 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.

  PMID: 25716971 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Atorvastatin; Formoterol Fumarate; lactitol; Lactose

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Robert M Mroz, MD

  Medical University of Bialystok, Bialystok, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2012
• First Posted: December 12, 2012
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

PL (1)