Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease
Conditions
Interventions
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,
Sponsors
Top Institute Pharma (TIPharma) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed