Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Inclusion Criteria:

* Prior to participation in the study all patients must sign and date an informed consent consistent with ICH-GCP guidelines.
* Male or female patients 40 years of age or older.
* Patients with a diagnosis of COPD according to BTS criteria..A stable disease state with airway obstruction of FEV1 between 30- 65% of predicted normal value and FEV1 /FVC\<70% pre bronchodilators.
* Predicted normal values will be calculated according to ECCS:
* For height measured in metres

  * Males: FEV1 predicted (L) = 4.30 X (Ht in mts) - 0.029 X (Age in yrs) - 2.49
  * Females:FEV1 predicted (L) = 3.95 X (Ht in mts) - 0.025 X (Age in yrs) - 2.60
* For height measured in inches

  * Males: FEV1 predicted (L) = 4.30 X (Ht in inches/39.37) - 0.029 X (Age in yrs) - 2.49
  * Females:FEV1 predicted (L) = 3.95 X (Ht in inches/39.37) - 0.025 X (Age in yrs) - 2.60
* Maintained on a stable respiratory medication for 4 weeks prior to visit 1 (no changes in respiratory medication oral dosage).
* Currently taking salbutamol or terbutaline MDI or DPI.
* Patient must be able to inhale medication through the HandiHaler?
* Patients must be able to perform technically acceptable pulmonary function tests in accordance with ATS criteria and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
* Pack Years = Number of cigarettes/day 20 (Patients who have never smoked cigarettes must be excluded.)

NOTE: An exacerbation of COPD requiring treatment occurring within the four week period prior to screening visit 1 will mean that screening should be postponed for at least four weeks. Therefore, the patient should have duration of at least 4 weeks free of exacerbations.

Exclusion Criteria:

* Patients with significant diseases, other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
* Patients who have taken inhaled anticholinergics in the previous 12 months. Patients that have been treated with inhaled anticholinergics (via nebuliser or metered dose inhaler) due to an exacerbation for a time period no longer than 7 days may be included.
* Patients with an upper respiratory tract infection or exacerbation of COPD requiring treatment in the four weeks prior to the screening visit (visit 1) or during the two-week run-in period.

Patients with a recent history (i.e., six months or less) of myocardial infarction.

* Any unstable or life threatening cardiac arrhythmia requiring intervention or a change in drug therapy within the last year.
* Patients with known active tuberculosis.
* Patients who have a history of thoracotomy with pulmonary resection or have planned lung transplantation or lung volume reduction surgery.
* Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
* Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions.
* Patients with a history of cancer in the last five years; Basal cell tumours or patients whose length of time in remission is greater than five years can be included.
* Patient with known hypersensitivity to atropine, and other anticholinergic drugs or lactose or any previous adverse reaction to anticholinergic drugs that resulted in withdrawal of the anticholinergic compound.
* Patients using oral corticosteroid medication at unstable doses (i.e. Patients have been on a stable dose for less than 6 weeks prior to randomisation) or at doses in excess of the equivalent of 10mg o
B: Inclusion Criteria:

* Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of \<=70%.
* At Screening \& Baseline, postbronchodilator FEV1 must be \>= 60% predicted normal \& \>=25% predicted normal.
* COPD symptoms for \>=24 months.
* \>=2 COPD exacerbations requiring course of oral corticosteroid \&/or antibiotics within 2-12 months before screening.
* Ex- or current smoker with smoking history \>=10 pack years.
* Only albuterol/salbutamol for relief for at least 2 weeks prior to randomization.
* Withdraw from parenteral \& oral steroids, anticholinergics, \& antibiotics 4 weeks prior to Screening.
* No harm in changing current COPD therapy, willing to discontinue his/her anticholinergics, inhaled corticosteroids (ICS) or ICS/long-acting beta agonists (LABA) at Screening, \& transferred to albuterol/salbutamol for relief for 2 weeks prior to Randomization.
* Lab tests conducted at Screening must be acceptable to investigator. Electrocardiogram (ECG) performed at Screening or within 30 days prior to Screening must be acceptable to investigator. Chest X-ray or computerized tomography (CT) scan is acceptable within 12 months prior to Screening must be acceptable to investigator.
* Female of childbearing potential must use birth control. Includes: hormonal contraceptives, intra-uterine device (IUD), condom in combination with spermicide, monogamous relationship with male partner who had vasectomy. Started birth control at least 3 months prior to Screening (exception condom), \& must agree to continue. Female who is not currently sexually active must agree/consent to using a method should she become sexually active. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.

Exclusion Criteria:

* Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate \& visit can be scheduled upon resolution. If there is evidence at Baseline, may be treated as appropriate \& visit can be rescheduled upon resolution.
* History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) hypertension treated with beta-blockers), active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB \[Fridericia or Bazett corrections, respectively \>500 milliseconds (msecs)\]) stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled \& stable (eg hypertension not requiring beta-blockers) will not prohibit participation if appropriate to investigator.
* Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients.
* Female who is breast-feeding, pregnant, or intends to become pregnant.
* Illicit drug user.
* Human immunodeficiency virus (HIV) positive (testing not conducted).
* Unable to correctly use oral MDI.
* Taking any restricted medications prior to Screening without meeting washout.
* Cannot adhere to permitted concomitant \& prohibited medications.
* May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time.
* Not be randomized into study more than once.
* No person directly associated with administration of study may participate.
* Previously participated in MF/F trial.
* Increase in absolute volume of \>=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.
* Asthma.
* Lobectomy, pneumonectomy or lung volume reduction surgery.
* Lung cancer.
* Requires long-term administration of oxygen (\>15 hours/day).
* Alpha-1-antitrypsin deficiency.
* A history and/or presence of intraocular pressure in either eye \>=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening:

  * nuclear opalescence (NO): \>=3.0,
  * nuclear color (NC): \>=3.0,
  * cortical cataract (C): \>=2.0,
  * posterior subcapsular (P): \>=0.5.
C: Inclusion Criteria:

* Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:

  1. Smoking history of at least 20 pack years
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  3. Post-bronchodilator FEV1/FVC (forced volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

     Exclusion Criteria:
* Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
* Patients who had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with a history of asthma.
* Patients with diabetes type I or uncontrolled diabetes type II.
* Any patient with lung cancer or a history of lung cancer.
* Patients with a history of certain cardiovascular co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.
D: Inclusion Criteria:

* Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Answer: C