Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control
Brief Summary: The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.


Options:
A: Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

* a) Smoking history of at least 10 pack-years
* b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
* Patients who have 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 comorbid conditions

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

1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:

   Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 \<=70% of predicted normal and FEV1 \<=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.

   For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60
2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
3. Male or female patients 40 years of age or older.
4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.
5. Patients must be current or ex-smokers with a smoking history of \>= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)
6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
7. Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).
8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.

Exclusion Criteria:

1. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
2. Patients with a diagnosis of asthma.
3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
4. Patients with known active tuberculosis.
5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
6. Patients with known narrow-angle glaucoma.
7. Patients with a history of myocardial infarction within the year prior to Visit 1.
8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
9. Patients with cardiac arrhythmia requiring medical or surgical treatment.
10. Patients with severe cardiovascular disorders.
11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other component of the medication delivery system.
12. Patients with known moderate or severe renal insufficiency (known creatinine clearance of \<= 50 mL/min).
13. Patients with untreated known hypokalaemia.
14. Patients with untreated known thyrotoxicosis.
15. Patients with brittle/unstable diabetes mellitus.
16. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
17. Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1).
18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
19. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and for the duration of the trial.
20. Previous participation (receipt of randomised treatment) in this study.
21. Patients who are currently participating in another study.
22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.
C: Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
* Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:

  1. Smoking history of at least 10 pack years (current or previous smokers)
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
  3. Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria:

* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long-term oxygen therapy for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit
* 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
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply.
D: * Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:

  * Stable moderate to severe airway obstruction
  * Baseline 30 % \< FEV1 \< 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
  * Baseline FEV1/SVC\< 70 %.
* Smoking history \> 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
* One pack of cigarettes per day for one year.
* History of exacerbation in the past year.

Answer: C