Clinical trial NCT02164539: Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Official title: 200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK573719
asthma
UMEC
FF
GSK2829332
persistent obstruction
GW685698
Fluticasone Furoate
COPD
umeclidinium bromide
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A
timeFrame: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)
measure: Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A
timeFrame: Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)
measure: Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A
timeFrame: Baseline and from Day 8 through Day 29
measure: Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28
timeFrame: Baseline and Day 28
measure: Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Sunset
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Union
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Morgantown
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: San Rafael
country: Argentina
facility: GSK Investigational Site
state: Mendoza
city: Rosario
country: Argentina
facility: GSK Investigational Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Mendoza
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucumán
country: Argentina
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Neu isenburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Teuchern
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Zgierz
country: Poland
facility: GSK Investigational Site
city: Znin
country: Poland
facility: GSK Investigational Site
city: Bacau
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Comuna Alexandru cel Bun
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Pitesti
country: Romania
facility: GSK Investigational Site
city: Ploiesti
country: Romania
facility: GSK Investigational Site
city: Ploiesti
country: Romania
facility: GSK Investigational Site
city: Timisoara
country: Romania
facility: GSK Investigational Site
city: Blagoveshchensk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: Sestroretsk
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lee L, Kerwin E, Collison K, Nelsen L, Wu W, Yang S, Pascoe S. The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. Respir Med. 2017 Oct;131:148-157. doi: 10.1016/j.rmed.2017.08.013. Epub 2017 Aug 14.