Phase 2
N=338
Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02164539 ↗Enrolled (actual)
338
Serious AEs
0.1%
Results posted
Jun 2016
Primary outcome: Primary: Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29) — 0.047; 0.146; 0.193; 0.175 Liters — p=0.024
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FF (Drug); UMEC (Drug); VI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29) |
0.047; 0.146; 0.193; 0.175; 0.143; 0.121 | 0.024 sig |
| SECONDARY Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A |
0.6; -0.4; -0.5; 0.0; -0.2; -0.1 | 0.010 sig |
| SECONDARY Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A |
0.5; -2.6; -2.5; -1.5; -1.5; -1.1 | <0.001 sig |
| SECONDARY 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 |
-14.2; 3.9; 7.6; 5.5; 10.5; 4.3 | 0.004 sig |
| SECONDARY Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28 |
0.048; 0.093; 0.088; 0.072; 0.052; 0.124 | 0.264 |
| SECONDARY Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28 |
0.249; 0.161; 0.159; 0.160; 0.189; 0.087 | 0.019 sig |
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 =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
Data sourced from ClinicalTrials.gov (NCT02164539). 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.