ADOAIR250 Anti-inflammatory Effects in Japanese Subjects With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01607398
First received: May 10, 2012
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: ADOAIR250
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in the number of neutrophils in sputum at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in all inflammatory cells, INF-gamma positive cells, and perforin-positive cells in sputum at 12 weeks [ Time Frame: 12weeks ] [ Designated as safety issue: No ]
  • Change from baseline in IL-8, MPO, hsCRP, and SP-D levels in sputum supernatant at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in IL-6, IL-8, hsCRP, SP-D, CC16, and fibrinogen levels in serum at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • respiratory function tests (FEV1, FVC) [ Time Frame: every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
  • CAT (COPD Assessment Test) [ Time Frame: every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
  • COPD exacerbations [ Time Frame: every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADOAIR250
ADOAIR 250mcg inhalations, twice daily, from week0 - 12
Drug: ADOAIR250
250 mcg inhalation, twice daily, from week0 -12.
Placebo Comparator: Placebo
Placebo inhalation, twice daily, from week0 -12
Drug: Placebo
Placebo inhalation, twice daily, from week0 -12.

Detailed Description:

This is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, 12-week-treatment study in Japanese patients with COPD.

At Visit 1, patients confirmed to be fulfilling all the inclusion criteria and not meeting any of the exclusion criteria will start the 4-week run-in period. During the entire study period, including the run-in period, the only drug allowed to use in addition to the study drug will be oxitropium (short-acting anticholinergic drug) as relief medication. At the end of the run-in period (Visit 2), subjects eligible for randomisation will be evenly randomised to one of the following two treatment groups and start the 12-week treatment period.

  • ADOAIR®250 one inhalation twice daily from the DISKUS inhaler
  • Placebo one inhalation twice daily from the DISKUS inhaler

Study completers will be defined as subjects who have completed all examinations, assessments, and study procedures in the study period, including the run-in period and the follow-up period. At completion/discontinuation of the treatment period, subjects will be switched to appropriate COPD treatment at the discretion of the investigator (or subinvestigator).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607398

Locations
Japan
GSK Investigational Site
Osaka, Japan, 559-0011
GSK Investigational Site
Osaka, Japan, 530-0001
GSK Investigational Site
Osaka, Japan, 545-8586
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01607398     History of Changes
Other Study ID Numbers: 116571
Study First Received: May 10, 2012
Last Updated: September 19, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by GlaxoSmithKline:
Japan
COPD
CAT
placebo
serum
Adoair250
anti-inflammatory
sputum

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014