Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)

Not Applicable

Conditions: -J449 Chronic obstructive pulmonary disease, unspecified
J449
Chronic obstructive pulmonary disease, unspecified

Registration Number: PER-030-07

Lead Sponsor: SCHERING PLOUGH DEL PERU S.A.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. A diagnosis of moderate to severe COPD based on a ratio ≤70% of FEV1 / FVC of pre-bronchodilator values.
2. In the Selection, the post-bronchodilator FEV1 must be ≤ 60% of what was predicted normal and ≥ 25% of the predicted normal.
3. The subject must have symptoms of COPD for at least 24 months.
4. The subject must have a documented history of two or more exacerbations of COPD that have required oral corticosteroid treatment and / or antibiotics in the period of 2 to 12 months before.
5. The subject must be a former smoker or a current smoker with a history of cigarette consumption> 1 pack of cigarettes per day for 10 years.
6. The subject should only have had a SABA / FDC treatment of short-acting anticholinergics for relief of discomfort, for at least 2 weeks before.
7. The subject should stop using parenteral steroids, long-acting anticholinergics, oral steroids and antibiotics 4 weeks before.
8. If, based on the investigator´s medical judgment, there is no inherent danger that the subject will change their current COPD therapy, the subject should be willing to discontinue their short-acting anticholinergics, the ICS or the ICS combination. / LABA prescribed in the Screening Visit and to be transferred to a treatment with SABA / short-acting anticholinergics for relief of discomfort 2 weeks before.
9. The subject must have two valid images, for the lumbar spine, total left femur and the femoral neck before randomization.
10. Clinical laboratory tests performed at the Screening Visit must be clinically acceptable. The electrocardiogram (ECG) performed must be clinically acceptable. A chest teleradiography performed at the Screening Visit or within the period of
12 months before the Screening Visit should be clinically acceptable.
11. The subject of the female sex with possibilities of getting pregnant should be using an adequate and medically acceptable method of birth control.

Exclusion Criteria

1. Subject demonstrating an increase in the absolute volume of> 400 mL at the Screening Visit or before the Start Day Visit during the 30 minutes after the administration of four albuterol / salbutamol inhalations, or 2.5 mg of albuterol / nebulized salbutamol.
2. Diagnosis of asthma.
3. Blood eosinophil count greater than 0.57 x 10-3 uL.
4. Subjects who have undergone a lobectomy, a pneumonectomy or surgery to reduce lung volume.
5. Diagnosis of lung cancer.
6. Subjects that require oxygen administration for long periods of time (> 15 hours per day).
7. Subjects experiencing an exacerbation of COPD requiring medical intervention at 8 weeks prior to randomization, use of oxygen therapy, B-blocking agents, or treatment with additional medication excluded.
8. Deficiency of alpha-1-antitrypsin.
9. Subjects with cataract extractions in both eyes.
10. Subjects with evidence of oropharyngeal candidiasis of clinical importance on the day of onset.
11. Subject with a history of renal, hepatic, cardiovascular, metabolic, neurological, hematological, ophthalmological, respiratory, gastrointestinal, cerebrovascular disease of clinical importance or with any other significant condition that could interfere with the study, or that requires treatment that could interfere with the study.
12. Subject with allergy / sensitivity to glucocorticoids, beta 2 agonists, study drug or its excipients.
13. Female subject who is lactating, who is pregnant or who is trying to get pregnant.
14. Subject that is known to be a user of an illicit drug.
15. Subject known to be HIV positive.
16. Subject who is unable to properly use an oral MDI inhaler.
17. Subjects who have been taking any of the restricted medications before the Selection without having met the required periods of time of pharmacological rest.
18. Subjects who can not adhere to the concomitant medications allowed and the medications prohibited.
19. Subjects participating in this study can not participate in this same study at another research center. In addition, a subject can not participate in a different research study in any other center in the same time period of this study.
20. The subject can not be randomized within the same study more than once.
21. No person directly associated with the administration of the study can participate as a subject of study. No member of the family of any member of the research team can participate in this study.
22. The subject who previously participated in a test with SCH 418131 (MF / F).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Criterion 1: Standard spirometry.<br>Criterion 2: An exacerbation of COPD can be defined as:<br>a) Deterioration that, in the opinion of the researcher, requires treatment with a course of antibiotics for lower airway disease.<br>b) Impairment that, in the opinion of the investigator, requires treatment with a course of oral steroids for lower airway disease.<br>c) COPD resulting in emergency treatment or hospitalization due to COPD.<br>Measure:1) AUC average (0-12 h) of the change in FEV1 for the comparison of the MF / F vs the MF. 2) Time to first exacerbation of COPD.<br>Timepoints:Criterion 1: Week 13.<br>Criterion 2: Week 52.<br>

Secondary Outcome Measures

Name	Time	Method

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