Please select the eligibility criteria that correspond to the clinical trial below.
Title: 200699: A Clinical Study to Evaluate Four Doses of Umeclidinium Bromide in Combination With Fluticasone Furoate in COPD Subjects With an Asthmatic Component
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.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of asthma
* Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
* FEV1 of fifty to ninety percent of predicted
* Currently using inhaled corticosteroid therapy
* History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Exclusion Criteria:

* History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
* Respiratory infection or oral candidiasis
* - Uncontrolled disease or clinical abnormality
* Allergies
* Taking another investigational medication or prohibited medication
B: Inclusion Criteria:

* Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
* Females of non-child bearing potential.
* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
* Pre-bronchodilator FEV1 \>70% of predicted at screening
* Subjects who are current non-smokers
* Methacholine challenge PC20 \< 8 mg/mL at screening
* Screening allergen challenge demonstrates that the subject experiences an early asthmatic response

Exclusion Criteria:

* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* Subject is hypertensive at screening
* Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
* History of life-threatening asthma
* Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
* Unable to abstain from short acting beta agonists
* Unable to abstain from antihistamines
* Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
* The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
* undergoing allergen desensitisation therapy
C: Inclusion Criteria:

1. Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study
2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory status of study medication permit enrolment of adults only) with a diagnosis of asthma as defined by the Global Initiative for Asthma \[GINA, 2009\] at least 12 weeks prior to Visit 1.
3. Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using an acceptable method of birth control consistently and correctly
4. Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value at the Visit 1 Screening visit. Predicted values will be based upon NHANES III using the Asian adjustment
5. Reversibility of Disease: Demonstrated ≥12% and ≥200mL reversibility of FEV1 within 10-40minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or one nebulized treatment with albuterol/salbutamol solution) at the Screening Visit.
6. Current Anti-Asthma Therapy: All subjects must be using an ICS, with or without LABA, for at least 12 weeks prior to Visit 1.
7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhaler at Visit 1 for use as needed for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 4 hours prior to study visits.

Exclusion Criteria:

1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 10 years.
2. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
5. Other Concurrent Diseases/Abnormalities: A subjects must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
6. Oropharyngeal Examination: A subject will not be eligible for the Run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
7. Allergies:

   * Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler
   * Milk Protein Allergy: History of severe milk protein allergy.
8. Concomitant Medications: Use of the protocol defined prohibited medications within the prohibited time intervals prior to Screening (Visit 1) or during the study.
9. Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, smokeless or pipe tobacco).
10. Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub Investigator, study coordinator, or employee of the participating Investigator.
11. Previous Participation: A subject may not have previously been randomized to treatment in another Phase III FF/VI combination product study
12. Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator ) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries
D: 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

Answer: D