Phase 4 Completed N=56 Randomized Quadruple-blind Treatment

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

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT01607398 ↗

Enrolled (actual)

Serious AEs

5.4%

Results posted

May 2014

Primary outcomePrimary: Change From Baseline in Neutrophil Count in Induced Sputum at Week 12 — 1.35; -6.00 ratio (%) — p=0.5146

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Neutrophil Count in Induced Sputum at Week 12	1.35; -6.00	0.5146
SECONDARY Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12	-0.0080; -0.0280	—
SECONDARY Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12	—	—
SECONDARY Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12	-5.0; -30.0	—
SECONDARY Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12	—	—
SECONDARY Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12	1.80; -23.90; 0.00; 0.00	—
SECONDARY Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12	0.30; 0.35; -1.80; -0.20	—
SECONDARY Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12	107.0; 23.5; -0.10; -0.20; -0.05; -0.05	—
SECONDARY Change From Baseline in Fibrinogen Levels in Serum at Week 12	—	—
SECONDARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12	0.035; 0.020; -0.035; -0.055	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12	0.1; -0.5	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12	-0.2; 0.0	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12	0.2; 0.0	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12	-0.7; 0.1	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12	0.1; 0.0	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12	-0.1; 0.1	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12	0.2; 0.0	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12	-0.1; 0.2	—
SECONDARY Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12	-0.5; -0.2	—
SECONDARY Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period	25; 26; 1; 0; 0; 0	—

Eligibility Criteria

Inclusion Criteria

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 = 40% to 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
Have known α1 antitrypsin deficiency
Previously enrolled in this study
Judged by the investigator (or subinvestigator) to be inappropriate to participate in this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01607398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.