Anti-inflammatory Effects of Caffeine in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Nowadays it has become evident that a chronic systemic inflammation is present in patients suffering from chronic obstructive pulmonary disease (COPD).

The role of the nuclear enzyme poly(adenosine diphosphate-ribose)polymerase (PARP) as a key mediator within these systemic inflammatory processes as well as in COPD associated exercise intolerance and muscle weakness could recently been identified. The attenuating effect of dietary ingredients with PARP inhibiting activity on systemic inflammation was supported by data from in vitro and in vivo studies, from other groups as well as from our own lab. We identified several caffeine metabolites as potent inhibitors of the most abundant PARP-isoform PARP-1 in-vitro, in animal models as well as in ex-vivo experiments with whole blood from COPD patients.

However, clinical data with respect to their anti-inflammatory effects in COPD patients are currently not available for none of these substances. Therefore, the current clinical pilot study is intended to establish for the first time clinical data (proof of principle) on the anti-inflammatory potential of caffeine metabolites.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magnesium is Associated With QoL in COPD: A Cross-sectional Study

NCT01564953

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED

The Occurence of Inflammation and Oxidative Stress in Lung Diseases

NCT00512967

Interstitial Lung Diseases Sarcoidosis Idiopathic Pulmonary Fibrosis +1 more

COMPLETED

A Study to Obtain Normal Values of Inflammatory Variables From Healthy Subjects

NCT00848406

Asthma Copd

COMPLETED

Responses Induced by Smoking in Individuals Being Susceptible and Non-Susceptible for Development of COPD

NCT00807469

Chronic Obstructive Pulmonary Disease

UNKNOWN

Systemic Inflammation in Chronic Obstructive Pulmonary Disease (COPD)

NCT00850863

Chronic Obstructive Pulmonary Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

500 mg caffeine capsules per day

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DIETARY_SUPPLEMENT

2 times 250 mg caffeine per day

2

500 mg placebo capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2 times 250 mg per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caffeine

2 times 250 mg caffeine per day

Intervention Type DIETARY_SUPPLEMENT

placebo

2 times 250 mg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* COPD GOLD stage II (50% ≤ FEV1\< 80%)
* CRP plasma levels ≥ 3 mg/l
* BMI \> 20 kg/m2 and \< 30 kg/m2
* Diastolic blood pressure (DBP)=60-90 mmHg, Systolic blood pressure (SBP)=100 150 mmHg

Exclusion Criteria

* Physical and/or mental disease or major surgery in the present or the past that might limit participation in or completion of the study
* Reported current or previous metabolic (e.g. diabetes), cardiovascular and/or renal diseases
* Known presence of a carcinoma
* Acute and/or chronic inflammatory condition such as arthritis, arthrosis, chronic colitis, etc. during three months before entry of the study
* Respiratory tract infection or exacerbation of COPD for at least 8 weeks prior to the start of the study
* Change in treatment regime of the COPD subjects for at least 8 weeks prior to the start of the study
* Use of laxatives, anti-diarrhoeal drugs and any other medication that can influence the uptake of the investigational products and/or influence their metabolism during the trial
* During the month prior to the start of the study and during the study the use of antibiotics and/or local and systemic steroidal (glucocorticoids) and non-steroidal anti-inflammatory drugs (NSAID)
* Abnormal constant dietary eating habits and a coffee consumption of less than 3 cups per day (i.e. a usual daily intake of \<400 mg caffeine).

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No