Last updated: 11/07/2018 11:49:15
Evaluation of umeclidinium bromide in combination with fluticasone furoate in COPD subjects with an asthmatic component
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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:
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)
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)
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
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
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
Interventions:
Drug: FF
Drug: UMEC
Drug: VI
Enrollment:
338
Observational study model:
Not applicable
Primary completion date:
2015-18-07
Time perspective:
Not applicable
Clinical publications:
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;131:148–157
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/umeclidinium bromide, fluticasone furoate/vilanterol, fluticasone furoate/vilanterol/umeclidinium bromide, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
July 2014 to July 2015
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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:
- History of life-threatening respiratory event within the last 5 years.
- Unresolved respiratory infection
Inclusion and exclusion criteria
Inclusion criteria:
- 18 years of age or older
- Outpatient subjects who are smokers or non-smokers.
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.
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 location(s)
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92117
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000DBS
Status
Study Complete
Location
GSK Investigational Site
Comuna Alexandru cel Bun, Romania, 617507
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1028AAP
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Teuchern, Sachsen-Anhalt, Germany, 06682
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucuman, Tucumán, Argentina, 4000
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-18-07
Actual study completion date
2015-18-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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