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

NCT01607398 | Completed Phase 4 Results

• 1 other identifier: 116571
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Japan; COPD; CAT; placebo; serum; Adoair250; anti-inflammatory; sputum

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Neutrophil Count in Induced Sputum at Week 12

  Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).

  Baseline and Week 12

Secondary Outcomes (19)

• Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12

  Baseline and Week 12

• Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12

  Baseline and Week 12

• Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12

  Baseline and Week 12

• Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12

  Baseline and Week 12

• Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12

  Baseline and Week 12

Study Arms (2)

ADOAIR250

EXPERIMENTAL

ADOAIR 250mcg inhalations, twice daily, from week0 - 12

Drug: ADOAIR250

Placebo

PLACEBO COMPARATOR

Placebo inhalation, twice daily, from week0 -12

Drug: Placebo

Interventions

ADOAIR250 DRUG

250 mcg inhalation, twice daily, from week0 -12.

ADOAIR250

Placebo DRUG

Placebo inhalation, twice daily, from week0 -12.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. )
• Have a diagnosis of COPD (defined as per the COPD guideline)
• Have a FEV1/FVC ratio \< 0.70 at 15-60 minutes following use of SALTANOL® INHALER
• Have a FEV1 of \>= 40% to \< 80% of the predicted normal value at 15-60 minutes following use of SALTANOL® INHALER
• Current or ex-smokers with a smoking history of at least 10 pack-years
• Able to use the DISKUS inhaler and the short-acting inhaled anticholinergic drug
• Capable of providing written voluntary consent to participate in the study

You may not qualify if:

• Diagnosed by the investigator (or subinvestigator) as having bronchial asthma
• Have any respiratory disorder other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis \[including old tuberculosis\], pulmonary fibrosis)
• 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.)
• Have chronic respiratory failure
• Have undergone lung volume reduction and/or lung transplant
• Have had a COPD exacerbation or respiratory infection requiring systemic corticosteroid or microbial therapy or hospitalisation, within 6 weeks prior to Visit 1
• Have used inhaled corticosteroids and systemic corticosteroids within 4 weeks prior to Visit 1
• Have used long-acting β2 agonists (inhaled or patch) within 2 weeks prior to Visit 1
• 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.)
• Receiving long-term oxygen therapy with oxygen use for more than 12 hours per day
• Have a concurrent serious or uncontrolled disease that might interfere with assessments in the study (including psychiatric disease, unstable liver disease, and heart disease)
• 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)
• Have participated in another study and received any other study drug within 4 weeks prior to Visit 1
• Diagnosed by the investigator (or subinvestigator) as having drug or alcohol dependence
• Have known or suspected hypersensitivity to bronchodilators, inhaled corticosteroid, or lactose

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Osaka, 530-0001, Japan

Location

GSK Investigational Site

Osaka, 545-8586, Japan

Location

GSK Investigational Site

Osaka, 559-0011, Japan

Location

Related Publications (1)

• 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 Apr 17;10:803-11. doi: 10.2147/COPD.S79842. eCollection 2015.

  PMID: 25945045 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 30, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-03

Locations

JP (3)