Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: FF; Drug: VI; Drug: UMEC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02164539

200699

Details and patient eligibility

About

The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older

• COPD with evidence of an asthmatic component as demonstrated by spirometry, reversibility and current therapy at screening as follows:

  • Post-bronchodilator morning (AM) FEV1 >=50% and <=80% of the predicted normal value at Visit 1
  • Pre- and post-bronchodilator FEV1/FVC ratio <0.7.
  • Demonstrated reversibility by >=12% and >=200 mL increase in FEV1 following albuterol at Visit 1.
  • A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist or leukotriene modifier, etc.) for a minimum of 12 weeks prior to Visit 1.

• Outpatient subjects who are smokers or non-smokers.

Exclusion criteria

• History of life-threatening respiratory event within the last 5 years.
• Unresolved respiratory infection
• Recent Severe COPD or Asthma Exacerbation
• Risk factors for pneumonia
• Hospitalization for pneumonia within 3 months
• Concurrent respiratory disease other than chronic obstructive pulmonary disease or asthma.
• Other uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
• Viral hepatitis or HIV
• Current or chronic history of liver disease, known hepatic or biliary abnormalities
• Drug or milk protein allergy
• Administration of prescription or over-the-counter medication that would significantly affect the course of COPD or asthma, or interact with study drug
• Subjects with lung volume reduction surgery within 12 months prior to screening.
• Use of long-term oxygen therapy (LTOT)
• Requirement for nebulized therapy
• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks
• Unstable or life-threatening cardiac disease
• Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding
• Diseases preventing the use of anticholinergics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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338 participants in 3 patient groups

Treatment Phase A

Experimental group

Description:

Eligible subjects will enter a 4-week run-in period and will receive fluticasone propionate/salmeterol. Subjects will then be randomized to receive fluticasone furoate 100 mcg, fluticasone furoate/umeclidinium bromide 100/15.6 mcg, fluticasone furoate/umeclidinium bromide 100/62.5 mcg, fluticasone furoate/umeclidinium bromide 100/125 mcg, fluticasone furoate/umeclidinium bromide 100/250 mcg, or fluticasone furoate/vilanterol 100/25 mcg, respectively for 4 weeks

Treatment:

Drug: FF

Drug: UMEC

Drug: VI

Treatment Phase B

Experimental group

Description:

Subjects completing Treatment Phase A will be randomized to receive either fluticasone furoate/umeclidinium bromide100/250 mcg or fluticasone furoate/umeclidinium bromide/vilanterol 100/250/25 mcg for 1 week.

Treatment:

Drug: FF

Drug: UMEC

Drug: VI

Treatment Phase C

Experimental group

Description:

Subjects completing Treatment Phase B will be randomized to receive either the same treatment as in Treatment Phase B, or the same treatment minus the umeclidinium bromide component, for 1 week.

Treatment:

Drug: FF

Drug: UMEC

Drug: VI