The Effects of Atorvastatin Treatment in COPD Patients

NCT ID: NCT01748279

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Atorvastatin

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

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Formoterol

Intervention Type: DRUG

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

Lactose tablet

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

Group Type: PLACEBO_COMPARATOR

Formoterol

Intervention Type: DRUG

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

Lactose tablet

Intervention Type: DRUG

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

Interventions

Atorvastatin

Intervention Type: DRUG

Formoterol

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

Intervention Type: DRUG

Lactose tablet

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

Intervention Type: DRUG

Other Intervention Names

Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900; Freiburg, Germany; Foradil, Novartis,

Eligibility Criteria

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.

3. Patients with moderate to very severe stable COPD (Stage II-IV) according to the GOLD guidelines.

4. Patients with a post-bronchodilator FEV1 < 80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 1.

5. Current or ex-smokers who have a smoking history of at least 10 pack years

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.

4. Patients with a clinically relevant laboratory abnormality at Visit 1 5. Patients with a history of malignancy of any organ system (including lung cancer).

6. Patients contraindicated for treatment with statins 7. Patients unable to perform acceptable spirometry and lung volumes procedures.

8. 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.

9. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

10. 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.

12. Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).

13. 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.

16. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.

17. 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Bialystok

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Mroz

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M Mroz, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Bialystok, Bialystok, Poland

Locations

Department of Lung Diseases and Tuberculosis, Medical University of Bialystok

Bialystok, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 25716971 (View on PubMed)

Other Identifiers

N N402 593440

Identifier Type: OTHER

Identifier Source: secondary_id

113-46-966

Identifier Type: -

Identifier Source: org_study_id