A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD). (ADC111114)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium Bromide; Drug: Fluticasone Propionate/Salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784550

111114

Details and patient eligibility

About

The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.

SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.

ADVAIR DISKUS® are registered trademarks of the GSK group of companies.

Enrollment: 342 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD diagnosis
• At least 10 pack year smoking history
• Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
• An FEV1/FVC ratio of less than or equal to 0.70

Exclusion criteria

• Current diagnosis of asthma
• Other respiratory disorder other than COPD
• Abnormal and clinical significant ECG
• Chest x-ray clinically significant abnormality not believed to be due to COPD
• Body Mass Index of greater than or equal to 40/kg/m2
• Use of Long Term Oxygen Therapy
• Lung resection surgery
• Women pregnant or lactating at Visit 1
• Previously diagnosed cancer unless in complete remission for 2 years at Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

342 participants in 2 patient groups

ADVAIR DISKUS® inhlaer Plus SPIRIVA® HANDIHALER® inhaler

Experimental group

Description:

Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Plus Tiotropium Bromide 18 mcg QD

Treatment:

Drug: Fluticasone Propionate/Salmeterol

SPIRIVA® HANDIHALER® inhaler

Active Comparator group

Description:

Tiotropium Bromide 18mcg QD plus Placebo DISKUS BID

Treatment:

Drug: Tiotropium Bromide