NCT00680641

Brief Summary

To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to placebo in a double-blind placebo-controlled study of patients with COPD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

May 16, 2008

Last Update Submit

August 4, 2011

Conditions

COPDEmphysema

Keywords

COPDEmphysemaSimvastatin

Outcome Measures

Primary Outcomes (1)

  • The difference in serum high sensitivity C-reactive protein (HsCRP) between simvastatin and placebo

    4 checks over a four month period at 2 weeks, 10 weeks, 14 weeks and 22 weeks.

Secondary Outcomes (7)

  • The difference between treatment with simvastatin and placebo for Clinical COPD Questionnaire

    4 months

  • The difference between treatment with simvastatin and placebo for Spirometry - FEV1, FVC, FEV1/FVC ratio

    4 months

  • The difference between treatment with simvastatin and placebo for Induced sputum differential cell count

    4 months

  • The difference between treatment with simvastatin and placebo for Induced sputum mRNA for MMP and TIMPs

    4 months

  • The difference between treatment with simvastatin and placebo for Exhaled breath condensate 8-isoprostane concentration

    4 Months

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

Simvastatin 40mg

Drug: Simvastatin

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SimvastatinDRUG

40mg of Simvastatin once daily

A
PlaceboDRUG

40mg of placebo once daily

B

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged more than 45 years.
  • Physician labelled diagnosis of chronic obstructive pulmonary disease,emphysema or chronic bronchitis.
  • Smoker or ex-smoker with a pack year smoking history of greater than 20 pack years
  • FEV1 30-70% predicted
  • FEV1/FVC\< 70%
  • Body Mass Index \<25kg/m2

You may not qualify if:

  • \. Cardiac or pulmonary disease other than chronic obstructive pulmonary disease.
  • Untreated hypothyroidism
  • Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.
  • Receiving current oral corticosteroid therapy or leukotriene modifying therapy.
  • Severe or uncontrolled co-morbid disease
  • History of atopy or asthma
  • Clinical history of bronchiectasis
  • Pregnancy or breastfeeding
  • Women of child-bearing potential, unless adequate contraception is used (ie contraceptive pill or double-barrier contraception - partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge)
  • Unable to give written informed consent
  • Patients receiving a statin prior to entry into the study
  • Hypersensitivity to simvastatin or to any of the excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRTU University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

CRTU Norfolk and Norwich University Hospital

Norwich, Norfolk, NR74UY, United Kingdom

Location

Related Publications (9)

  • Hothersall E, McSharry C, Thomson NC. Potential therapeutic role for statins in respiratory disease. Thorax. 2006 Aug;61(8):729-34. doi: 10.1136/thx.2005.057976.

    PMID: 16877692BACKGROUND

  • Soyseth V, Brekke PH, Smith P, Omland T. Statin use is associated with reduced mortality in COPD. Eur Respir J. 2007 Feb;29(2):279-83. doi: 10.1183/09031936.00106406. Epub 2006 Oct 18.

    PMID: 17050558BACKGROUND

  • Hanefeld M, Marx N, Pfutzner A, Baurecht W, Lubben G, Karagiannis E, Stier U, Forst T. Anti-inflammatory effects of pioglitazone and/or simvastatin in high cardiovascular risk patients with elevated high sensitivity C-reactive protein: the PIOSTAT Study. J Am Coll Cardiol. 2007 Jan 23;49(3):290-7. doi: 10.1016/j.jacc.2006.08.054. Epub 2007 Jan 8.

    PMID: 17239709BACKGROUND

  • Kevorkian L, Young DA, Darrah C, Donell ST, Shepstone L, Porter S, Brockbank SM, Edwards DR, Parker AE, Clark IM. Expression profiling of metalloproteinases and their inhibitors in cartilage. Arthritis Rheum. 2004 Jan;50(1):131-41. doi: 10.1002/art.11433.

    PMID: 14730609BACKGROUND

  • Montuschi P. Exhaled breath condensate analysis in patients with COPD. Clin Chim Acta. 2005 Jun;356(1-2):22-34. doi: 10.1016/j.cccn.2005.01.012. Epub 2005 Mar 23.

    PMID: 15936301BACKGROUND

  • Kasielski M, Nowak D. Long-term administration of N-acetylcysteine decreases hydrogen peroxide exhalation in subjects with chronic obstructive pulmonary disease. Respir Med. 2001 Jun;95(6):448-56. doi: 10.1053/rmed.2001.1066.

    PMID: 11421501BACKGROUND

  • van der Molen T, Willemse BW, Schokker S, ten Hacken NH, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003 Apr 28;1:13. doi: 10.1186/1477-7525-1-13.

    PMID: 12773199BACKGROUND

  • Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.

    PMID: 8756799BACKGROUND

  • Standardization of spirometry--1987 update. Statement of the American Thoracic Society. Am Rev Respir Dis. 1987 Nov;136(5):1285-98. doi: 10.1164/ajrccm/136.5.1285. No abstract available.

    PMID: 3674589BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysema

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Andrew M Wilson, MD, MRCP (UK)

    Clinical Senior Lecturer, University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2012

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

GB(2)