Condition category
Respiratory
Date applied
30/06/2009
Date assigned
04/09/2009
Last edited
04/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erica Rutten

ORCID ID

Contact details

Center of expertise for chronic organ failure (Ciro) Horn
P.O. Box 4080
Horn
6080 AB
Netherlands
ericarutten@proteion.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The contribution of the intestinal permeability in the systemic inflammation of patients with chronic obstructive pulmonary disease (COPD) during acute exercise: an observational case-control study

Acronym

IPEX

Study hypothesis

Intestinal permeability increases during an acute exercise load and plays a role in the systemic inflammation in moderate to severe patients with COPD.

Ethics approval

Not provided at time of registration

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

No intervention study.

The study design includes three test days. During day 1, intestinal permeability at rest will be measured. When a blood samples is taken and urine is collected, subjects will ingest a sugar solution in the fasted state after which urine will be collected for 5 hours. In blood and urine, markers for intestinal permeability will be measured. Day 2 and 3 , the same study procedure will take place after the performance of an acute exercise load. The exercise will include a submaximal ergomtery test at 50% of their Wmax or an activity of daily living (ADL) test. The ADL test exist of a combination of several daily activities:
ADL 1: dressing socks, shoes and a coat
ADL 2: fold up 8 towels and put them in the laundry basket
ADL 3: put 6 cans (all 400 g) in a shopping basket
ADL 4: washing 4 plates, 4 cups and 4 saucers and put them in a plate rack
ADL 5: for 4 minutes sweeping plastic blocks with a broom

The mobile Oxycon will measure the ventilated effort (VO2 and ventilation [VE]) in order to calculate the metabolic response of the activities.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Markers for intestinal permeability:

In plasma and collected in the post-absorptive state or immediately after exercise:
1. Intestinal fatty acid binding protein (IFABP);
2. Ileal lipid-binding protein (ILBP);
3. Claudine

In urine, 5 hours after ingestion of the sugar solution:
4. Urinary concentration of various sugars

Secondary outcome measures

1. Markers of systemic inflammation in plasma collected in the post-absorptive state
2. Markers of respiratory permeability (surfactant D) in plasma collected in the post-absorptive state

Overall trial start date

01/10/2009

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of COPD Global Initiative for chronic Obstructive Lung Disease (GOLD) stage II or III according to the American Thoracic Society (ATS) GOLD guidelines (forced expiratory volume in one second [FEV1] between 30% and 80% predicted and FEV1/forced vital capacity [FVC] less than 70%, and less than 10% predicted improvement in FEV1 after B2-agonist inhalation)
2. Both male and female, age-range from 40 to 75 years
3. No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study
4. Capable to provide informed consent
5. Presence of other non-gastro-intestinal related and non-renal chronic diseases are allowed in case the clinical status is stable for at least 4 weeks before the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 COPD subjects and 35 control subjects

Participant exclusion criteria

1. External oxygen supplementation at rest
2. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
4. Any kind of gastro-intestinal complaints or gastro-intestinal disease
5. The presence of cardiovascular disease, assessed by analyses of plasma pro-brain natriuretic peptide (pro-BNP) levels
6. Use of non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, acetylsalicic acid, naproxen, meloxicam, diclofenac) or antibiotics or oral corticosteroids at least 4 weeks before the study

Recruitment start date

01/10/2009

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Center of expertise for chronic organ failure (Ciro) Horn
Horn
6080 AB
Netherlands

Sponsor information

Organisation

Top Institute Pharma (TIPharma) (Netherlands)

Sponsor details

Wassenaarseweg 72
Leiden
2333 AL
Netherlands

Sponsor type

Industry

Website

http://www.tipharma.com/pro1/general/home.asp

Funders

Funder type

Industry

Funder name

Top Institute Pharma (TIPharma) (Netherlands)

Alternative name(s)

TI Pharma

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes