Evaluation of umeclidinium bromide in combination with fluticasone furoate in COPD subjects with an asthmatic component
Trial overview
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
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
Participation 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:
- History of life-threatening respiratory event within the last 5 years.
- Unresolved respiratory infection
- 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.
- 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)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.