Last updated: 11/07/2018 10:35:16
ADOAIR250 anti-inflammatory effects in Japanese subjects with chronic obstructive pulmonary disease
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 12-week randomised, double-blind, parallel-group study to evaluate the anti-inflammatory effects of ADOAIR® 50/250mcg twice daily compared with placebo twice daily in Japanese subjects with chronic obstructive pulmonary disease (COPD)
Trial description: The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in neutrophil count in induced sputum at Week 12
Timeframe: Baseline and Week 12
Secondary outcomes:
Change from Baseline in all inflammatory cell count in induced sputum at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in Interferon (INF)-gamma-positive cells and perforin-positive cells in sputum at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in Interleukin (IL)-8 levels in sputum supernatant at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in high-sensitivity C-reactive protein (hsCRP) levels in sputum supernatant at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D levels in sputum supernatant at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in IL-6 and IL-8 levels in serum at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) levels in serum at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in fibrinogen levels in serum at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 1 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 2 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 3 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 4 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 5 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 6 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 7 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) Question 8 score at Week 12
Timeframe: Baseline and Week 12
Change from Baseline in the COPD Assessment Test (CAT) total score at Week 12
Timeframe: Baseline and Week 12
Number of participants who experienced the indicated number of COPD exacerbations during the Treatment Period
Timeframe: From Baseline up to Week 12
Interventions:
Drug: ADOAIR250
Drug: Placebo
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2013-10-07
Time perspective:
Not applicable
Clinical publications:
Asai K, Kobayashi A, Makihara Y, Johnson M.Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease.Int J Chron Obstruct Pulmon Dis.2015;10(1):803-811
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
May 2012 to July 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 1) Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female patients may be enrolled only if they are not of child-bearing potential, or are of child-bearing potential who agree to properly use protocol-specified contraceptive measures. )
- 2) Have a diagnosis of COPD (defined as per the COPD guideline)
- 1) Diagnosed by the investigator (or subinvestigator) as having bronchial asthma
- 2) Have any respiratory disorder other than COPD
Inclusion and exclusion criteria
Inclusion criteria:
- 1) Japanese (male or female) outpatients aged 40-80 years inclusive at Visit 1 (Female patients may be enrolled only if they are not of child-bearing potential, or are of child-bearing potential who agree to properly use protocol-specified contraceptive measures. ) 2) Have a diagnosis of COPD (defined as per the COPD guideline) 3) Have a FEV1/FVC ratio < 0.70 at 15-60 minutes following use of SALTANOL® INHALER 4) Have a FEV1 of >= 40% to < 80% of the predicted normal value at 15-60 minutes following use of SALTANOL® INHALER 5) Current or ex-smokers with a smoking history of at least 10 pack-years 6) Able to use the DISKUS inhaler and the short-acting inhaled anticholinergic drug 7) Capable of providing written voluntary consent to participate in the study
Exclusion criteria:
- 1) Diagnosed by the investigator (or subinvestigator) as having bronchial asthma 2) Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis [including old tuberculosis], pulmonary fibrosis) 3) Have a chest X-ray (or CT scan) 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 Visit 1; or, a chest X-ray must be obtained at Visit 1.) 4) Have chronic respiratory failure 5) Have undergone lung volume reduction and/or lung transplant 6) Have had a COPD exacerbation or respiratory infection requiring systemic corticosteroid or microbial therapy or hospitalisation, within 6 weeks prior to Visit 1 7) Have used inhaled corticosteroids and systemic corticosteroids within 4 weeks prior to Visit 1 8) Have used long-acting β2 agonists (inhaled or patch) within 2 weeks prior to Visit 1 9) Are unable to stop their short-acting β2 agonist therapy at Visit 1 (During the study participation, oxitropium bromide (TERSIGAN) will be used as relief medication.) 10) Receiving long-term oxygen therapy with oxygen use for more than 12 hours per day 11) Have a concurrent serious or uncontrolled disease that might interfere with assessments in the study (including psychiatric disease, unstable liver disease, and heart disease) 12) Have a QTc > 450 msec (or > 480 msec in patients with bundle branch block) at Visit 1 (based on average QTc from three consecutive cardiac cycles on ECG) 13) Have participated in another study and received any other study drug within 4 weeks prior to Visit 1 14) Diagnosed by the investigator (or subinvestigator) as having drug or alcohol dependence 15) Have known or suspected hypersensitivity to bronchodilators, inhaled corticosteroid, or lactose 16) Have known α1 antitrypsin deficiency 17) Previously enrolled in this study 18) Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-10-07
Actual study completion date
2013-10-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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