Last updated: 11/07/2018 10:47:40

Investigation of airway inflammation in Japanese COPD patients, smoking controls and non-smoking controls

GSK study ID
116768
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Investigation of airway inflammation in Japanese COPD patients, smoking controls and non-smoking controls
Trial description: The primary objective of the study is to demonstrate that Japanese patients with COPD exhibit airway and systemic inflammation compared to both 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:
Not applicable
Interventions:
Not applicable
Enrollment:
100
Primary completion date:
Not applicable
Observational study model:
Case-Control
Time perspective:
Prospective
Clinical publications:
Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M.Airway inflammation in Japanese COPD patients compared with smoking and non-smoking controls.Int J Chron Obstruct Pulmon Dis.2015;10(1):185-192
Medical condition
Lung Injury, Acute and Respiratory Distress Syndrome, Adult
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
September 2013 to November 2013
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
  • Any other respiratory disease
  • e.g.
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 (pre-BD, FEV1/FVC ≥0.8)
  • 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 (Pre-BD FEV1/FVC ≥0.8)
  • Informed consent COPD
  • Males and females ≥40years of age
  • Ex smokers or current smokers with≥10 pack year smoking history
  • Pre-BD FEV1/FVC<0.7, 40% < %FEV1 <70%
  • Informed consent
  • Cough and sputum in the previous 2 weeks to identify the CB phenotype
Exclusion criteria:
  • Any other respiratory disease e.g.
  • Chronic bronchitis without airflow limitation
  • Lung cancer
  • Asthma
  • bronchiectasis
  • pulmonary fibrosis
  • Other diseases below:
  • Head and neck cancer
  • Rheumatism
  • Clinically significant chronic cardiac, renal, or hepatic medical condition
  • Acute respiratory event including COPD exacerbations within the last 4 weeks
  • Medication with ICS/LABA (ICS and/or LABA) within the last 4 weeks
  • Medication with low dose xanthine (which may have an anti-inflammatory effect)

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)

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
2013-05-11

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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