COPDPhase 4NCT01748279
The Effects of Atorvastatin Treatment in COPD Patients
A Phase 4 study testing Atorvastatin, Formoterol and Lactose tablet in people with COPD, run by Medical University of Bialystok at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Atorvastatin, Formoterol and Lactose tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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
Who cannot join
- 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.
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Lung Diseases and Tuberculosis, Medical University of Bialystok
Bialystok, 15-540
About this study
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
- Being tested
- Atorvastatin, Formoterol, Lactose tablet
- Keywords
- COPD, Atorvastatin, statins, COPD treatment, microarrays
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900, Freiburg, Germany
FormoterolDrug
Also called Foradil, Novartis,
12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
Lactose tabletDrug
One lactose tablet taken once a day as add-on treatment to Formoterol therapy
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | 40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy. Receives: Drug: Atorvastatin; Drug: Formoterol |
| Lactose tablet | Placebo comparator | One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy. Receives: Drug: Formoterol; Drug: Lactose tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks
Secondary outcomes (5)
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
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
Change in hs-CRP over study period
Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Mroz, Medical University of Bialystok
- Investigators
- Robert M Mroz, MD, Principal investigator, Medical University of Bialystok, Bialystok, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748279
- Sponsor's protocol ID
- 113-46-966
- Other IDs
- N N402 593440
- Status last verified
- Apr 2013
- First submitted
- 9 Dec 2012
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Atorvastatin Treatment in COPD Patients
- ClinicalTrials.gov ID
- NCT01748279
- Acronym / sponsor ID
- 113-46-966
- Conditions
- COPD
- Keywords
- COPD, Atorvastatin, statins, COPD treatment, microarrays
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin, Drug: Formoterol40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy. |
| Lactose tablet | Placebo comparator | Drug: Formoterol, Drug: Lactose tabletOne tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . 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
Key exclusion criteria (11 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900, Freiburg, Germany | Drug | Atorvastatin |
| FormoterolAlso: Foradil, Novartis,12mcg of Foradil BID as maintenance COPD treatment in both treatment arms | Drug | Atorvastatin, Lactose tablet |
| Lactose tabletOne lactose tablet taken once a day as add-on treatment to Formoterol therapy | Drug | Lactose tablet |
Primary outcome
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
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
5 secondary outcomes
Change in health related quality of life over study period
Time frame: 12 weeks
Change in 6-Minute Walk Distance over study period
Time frame: 12 weeks
Change in intimal-medial thickness over study period
Time frame: 12 weeks
Change in hs-CRP over study period
Time frame: 12 weeks
Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Derived from this study: PubMed 25716971Mroz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Mroz, MD principal investigator
Medical University of Bialystok, Bialystok, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin, Formoterol and Lactose tablet in people with COPD, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD45+ cells expression over study period (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.