Clinical trial NCT00383435 (phase 3, status: completed)
Conditions: chronic obstructive pulmonary disease (copd)
ICD codes: G91.1, I42.1, N11.1, J05.0, G47.33, J44.9, N13.8
Drugs: mometasone furoate/formoterol (mf/f) combination, mometasone furoate/formoterol (mf/f) combination, mometasone furoate mdi (mf mdi), formoterol mdi, placebo
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC)
             ratio of <=70%.

          -  At Screening, postbronchodilator FEV1 must be <=60% predicted normal & >=25% predicted
             normal.

          -  COPD symptoms for >=24 months.

          -  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 at least 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 Visit or within 30 days prior to Screening must be
             acceptable to investigator. Chest x-ray performed at Screening or within 12 months
             prior to Screening must be acceptable to investigator.

          -  Women who have

        been surgically sterilized or are at least 1 year postmenopausal are not

        considered to be of childbearing potential. A female subject of childbearing

        potential must have a negative serum pregnancy test at Screening in order to

        be considered eligible for enrollment. 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), & agree to
        continue. Female who is not currently sexually active must agree/consent to use a method
        should she become sexually active. Women 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 Visit, 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 being 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 deemed appropriate per 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 of study.

          -  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.

          -  Blood eosinophil count greater than 0.57 x 10^3/microliter (uL).

          -  Lobectomy, pneumonectomy or lung volume reduction surgery.

          -  Lung cancer.

          -  Requires long-term administration of oxygen (>15 hours per day).

          -  A subject who experiences an exacerbation of COPD requiring medical

        intervention within 4 weeks prior to randomization, beta-blocking agents, or

        treatment with additional excluded medication (other than short-acting beta agonists
        (SABA)/short-acting

        anticholinergic to be used as rescue medication).

          -  alpha-1-antitrypsin deficiency.

          -  Cataract extractions on both eyes.

          -  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.