Last updated: 11/07/2018 11:14:01
Inflammatory responsiveness of peripheral blood mononuclear cell (PBMC) and sputum cells taken from Japanese patients with chronic obstructive pulmonary disease (COPD), smoking controls and non-smoking controls
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Inflammatory responsiveness of peripheral blood mononuclear cell (PBMC) and sputum cells taken from Japanese patients with chronic obstructive pulmonary disease (COPD), smoking controls and non-smoking controls
Trial description: The primary objective of the study is to demonstrate that PBMC and sputum cells from Japanese patients with COPD exhibit increased inflammatory responsiveness compared with smoking and non-smoking controls.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Inflammation biomarkers
Timeframe: N/A
Secondary outcomes:
Inflammation mediators (cell count)
Timeframe: N/A
Interventions:
Not applicable
Enrollment:
30
Primary completion date:
Not applicable
Observational study model:
Case-Control
Time perspective:
Prospective
Clinical publications:
Kawayama,T; Kinoshita,T; Matsunaga,K; Kobayashi,A; Hayamizu,T; Johnson,M ; Hoshino,T.Responsiveness of blood and sputum inflammatory cells in Japanese COPD patients, non-COPD smoking controls, and non-COPD nonsmoking controls.Int J Chron Obstruct Pulmon Dis.2016;11:295-303.
Medical condition
Lung Injury, Acute and Respiratory Distress Syndrome, Adult
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
March 2014 to June 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
none
- Non-smoking Control (NSC)
- Males and females ≥40years of age
- 1. Diagnosed by the investigator (or subinvestigator) as having asthma
- 2. Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis)
Inclusion and exclusion criteria
Inclusion criteria:
- Non-smoking Control (NSC) Males and females ≥40years of age Smoking history <1 pack year Lung function is normal (FEV1/FVC ≥0.7) Informed consent Smoking control (SC) Males and females ≥40years of age Ex smokers or current smokers with >10 pack year smoking history Lung function is normal (FEV1/FVC ≥0.7) Informed consent COPD Males and females ≥40years of age Ex smokers or current smokers with≥10 pack year smoking history FEV1/FVC<0.7 Informed consent Cough and sputum in the previous 2 weeks to identify the CB phenotype
Exclusion criteria:
- 1. Diagnosed by the investigator (or subinvestigator) as having asthma 2. Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis) 3. Have had a COPD exacerbation or respiratory infection within 4 weeks prior to the study 4. Have a chest CT scan (or X-ray) indicating a diagnosis other than COPD that might interfere with assessments in the study (This must be assessed using last imaging study performed within 6 months prior to the study; or, a chest CT scan must be obtained at the visit.) 5. Have bacterial infection, virus infection (including virus hepatitis), systemic inflammation (rheumatism, connective tissue disease, systemic erythematodes, etc.) 6. Have known α1 antitrypsin deficiency 7. Have undergone lung volume reduction and/or lung transplant 8. Have taken inhaled steroid and/or systemic steroid within 4 weeks prior to the study 9. Have taken low dosage xanthine within 4 weeks prior to the study (Using normal dosage of xanthin is possible) 10. Have participated in other clinical study and taken investigational product within 4 weeks prior to the study 11. Previously enrolled in this study 12. Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2014-23-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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