Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Evaluation of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
