Clinical trial NCT02242227 (phase 2, status: completed)
Conditions: pulmonary disease, chronic obstructive
ICD codes: J44.9, J44.1, J44.0
Drugs: salmeterol xinafoate, serevent® diskus®, placebo (handihaler®), placebo (diskus®)
SMILES: OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  All patients must sign an informed consent consistent with International Conference on
             Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior
             to any study-related procedures, which includes medication washout and restrictions

          -  All patients must have a diagnosis of chronic obstructive pulmonary disease and must
             meet the following spirometric criteria:

               -  Patients must have relatively stable* airway obstruction with a pre-dose FEV1 ≤
                  60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2.

                    -  *The enrolment of patients who have had an exacerbation within six weeks
                       prior to planned study entry should be postponed

          -  At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the
             pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol
             (Sultanol® MDI)

          -  Male or female patients 40 years of age or older

          -  Patients must be current or ex-smokers with a smoking history of more than 10
             pack-years ((Patients who have never smoked cigarettes must be excluded)

          -  Patients must be able to perform technically acceptable pulmonary function tests
             during the study period as required in the protocol

          -  Patients must be able to inhale medication in a competent manner from the HandiHaler®
             2 device and the Diskus® device

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

          -  Patients who have been hospitalized for heart failure (New York Heart Association
             (NYHA) class III or IV) within the past year

          -  Patients with any unstable or life threatening cardiac arrhythmia or cardiac
             arrhythmia requiring intervention or a change in drug therapy within the past year

          -  Patients with malignancy for which the patient has undergone resection, radiation
             therapy or chemotherapy within the last five years. Patients with treated basal cell
             carcinoma are allowed

          -  Patients with a history of asthma, allergic rhinitis or atopy or who have a total
             blood eosinophil count ≥600/mm3

          -  Patients with a history of life threatening pulmonary obstruction, or a history of
             cystic fibrosis or clinically evident bronchiectasis

          -  Patients with known active tuberculosis

          -  Patients with significant alcohol or drug abuse within the past two years

          -  Patients who have undergone thoracotomy with pulmonary resection. Patients with a
             history of thoracotomy for other reasons should be evaluated as per exclusion
             criterion No. 1

          -  Patients who have completed a pulmonary rehabilitation program in the six weeks prior
             to the Screening Visit (Visit 1) or patients who are currently in a pulmonary
             rehabilitation program that will not be maintained throughout the duration of the
             study

          -  Patients who regularly use daytime oxygen therapy for more than one hour per day and
             in the investigator's opinion will be unable to abstain from the use of oxygen therapy

          -  Patients who are being treated with antihistamines (H1 receptor antagonists),
             antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic
             conditions

          -  Patients who have been treated with cromolyn sodium or nedocromil sodium within one
             month prior to Visit 1 or during the run-in period

          -  Patients using oral corticosteroid medication at unstable doses (i.e., less than six
             weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone
             per day or 20 mg every other day

          -  Patients with known hypersensitivity to beta-adrenergics, lactose or any other
             components of the inhalation capsule delivery system or the Diskus®

          -  Pregnant or nursing women or women of childbearing potential not using a medically
             approved means of contraception for the previous three months (i.e. oral
             contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.:
             Norplant®)

          -  Patients who have taken an investigational drug within one month or six half lives
             (whichever is greater) prior to Visit 1

          -  Patients who have been treated with oral beta-adrenergics within one month prior to
             Visit 1 or during the run-in period

          -  Patients who have been treated with theophylline preparations within one month prior
             to Visit 1 or during the run-in period

          -  Patients who have been treated with the long-acting anticholinergic tiotropium
             (Spiriva®) within one month prior to Visit 1 or during the run-in period

          -  Patients with any respiratory infections in the six weeks prior to the Screening Visit
             (Visit 1) or during the run-in period. In the case of a respiratory infection during
             the run-in period the latter may be extended up to six weeks

          -  Patients who are currently participating in another study