Multiorgan Pathology in Chronic Obstructive Pulmonary Disease (COPD)

NCT00864994 | Unknown DMC

• 1 other identifier: 23475
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is increasing evidence in the literature that COPD should not be considered as a localised pulmonary disorder but as a systemic disease involving pathology in several extra pulmonary tissues. Well characterized systemic features are a chronic low grade systemic inflammation, altered body composition and a skeletal muscle fibre type shift. There are indications that an absolute or relative increase of fat mass puts COPD patients at increased risk for cardiovascular pathology while muscle atrophy is associated with a high prevalence of osteoporosis and with impaired physical function. The origin of systemic inflammation is poorly understood. Both endogenous and exogenous risk factors contribute to systemic inflammation and extra-pulmonary manifestations of COPD. Overall objective of study 3: To compare the pattern and severity of the systemic inflammatory profile in relation to skeletal muscle weakness and cardiovascular risk profile in COPD patients with mild to moderate disease compared to non-susceptible smokers. Specific objectives:

• 30 healthy subjects who after 20 pack years smoking have no signs of COPD (age 40-75 years)
• 30 COPD patients with GOLD stage II (age 40-75 years)

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Inflammation; Smoking; Multiorgan pathology; Extra pulmonary manifestations

Outcome Measures

Primary Outcomes (13)

• Smoking history and behaviour, diet and physical activity level assessed by questionnaire

• Extensive lung function and CT scanning of the lung, ECG

• Candidate genes for muscle dysfunction and CVD risk

• Body composition

• Systemic inflammation

• Advanced Glycosylated Endproduct (AGE)

• Glucose Tolerance Test

• Risk factors of metabolic syndrome

• 6 minutes walking distance

• Handgrip strength

• Skeletal muscle function by isokinetic dynamometry

• Physical activity level and pattern by accelerometry

• Muscle oxidative phenotype, fibre cross-sectional area and molecular signatures obtained in vastus lateralis muscle biopsies before and after incremental cycle ergometry

Study Arms (2)

1

• 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years)

2

• 30 COPD patients with GOLD stage II (age 40-75 years)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Totally 60 subjects will be included * 30 healthy subjects with 20 pack years smoking who have no signs of COPD (age 40-75 years) * 30 COPD patients with GOLD stage II (age 40-75 years)

You may qualify if:

• Age 40-75 years
• Age, pack years, FEV1/FVC and FEV1% predicted must fit in one of 2 groups of table 4.3
• Physically and mentally able to undergo the total study protocol
• Written informed consent

You may not qualify if:

• Participation in another study
• Alpha-1-antitrypsin deficiency
• Selected grade 1-3 co-morbidity listed in the ACE-27
• Active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis
• Active extra-pulmonary infection like hepatitis A-C, cystitis, gastroenteritis etc.
• Pulmonary diseases like sarcoidosis, IPF, silicosis, hypersensitivity pneumonitis, asthma
• Life threatening diseases like carcinoma, AIDS (including HIV+), acute leukemia etc.
• Medication that may affect the results of the study: NSAID's, immunosuppressive agents like prednisolon, methotrexate, azathioprine, sintrom tablets, askal
• Antibiotic or prednisolon use in the past 2 months

Sponsors & Collaborators

• Top Institute Pharma: lead
• University Medical Center Groningen: collaborator
• Maastricht University Medical Center: collaborator
• UMC Utrecht: collaborator
• Danone Institute International: collaborator
• GlaxoSmithKline: collaborator
• Nycomed: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Maastricht University Medical Center, Dept. of Respiratory Medicine

Maastricht, Limburg, 6200 MD, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be retained to investigate differences in candidate genes (SNPs) for COPD and CVD between the different groups.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Emiel Wouters, Prof. dr. MD

  Maastricht University Medical Center, Dept. of Respiratory Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AMWJ Schols, Prof. dr. ir.

CONTACT

+31 43 387 5046; a.schols@pul.unimaas.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: September 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 29, 2010

Record last verified: 2010-09

Locations

NL (1)