None listed
Conditions
Interventions
Subjects will be randomized in a 1: 1 ratio, to 52 weeks of treatment with Mometasone Furoate MF-DPI dry powder inhaler X 800 mcg QPM.
Group name:Group 2 Type of group
Group 1 Type of group
Subjects will be randomized to 52 weeks of Placebo treatment of mometasone furoate in DPI QPM dry powder inhaler.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must be 40 years of age or older, belong to any sex and race. 2. They must have a clinical history of COPD. 3. Must be current smokers or former smokers who quit at least a year ago. Subjects must have a history of a minimum smoker of 10 years (20 cigarettes). The years-tied are calculated by multiplying the average of daily cigarette bundles by the number of years. Subjects who have been exposed in a clinically significant manner to smoke from wood-burning ovens in enclosed spaces for a minimum of 5 years also meet the inclusion criteria. 4. Must have been using inhaled corticosteroids daily for at least 3 months before screening. 5. The FEV1: FVC ratio of the patient before the administration of the bronchodilator at the Screening Visit and the Baseline Visit should be ≥70%. Pre FEV1 x 100 ¼ 70% Pre FVC 6. After 400 mcg of salbutamol released by a MID using a spacer device or a DPI, the reversibility in FEV1 should be <10% of the predicted FEV1, in the Selection and in the Baseline Visit. Post FEV1 – Pre FEV1 X 100 <10% FEV1 predicted 7.FEV1 after administration of the bronchodilator should be <70% of the expected normal as well as ≥30% of the expected normal or 800 ml (whichever is less) both at the Screening Visit and at the Baseline Visit. Post FEV1 X 100 1/4 70%, 3/4 30% or 8OO mL FEV1 predicted 8. Clinical laboratory tests (CBC, blood chemistry, urinalysis) must be within normal limits or be clinically acceptable to the Investigator / Sponsor. 9. The subjects must be willing to give written informed consent and be able to respect the visits and dose schedules. 10. Subjects must agree to inform their usual treating physician about their participation in this study. 11. Women of childbearing age who are not pregnant should be using an adequate, medically acceptable method of contraception that includes: 1) hormonal contraceptive prescribed by a doctor (eg, oral combination, hormonal implant, slow absorption injectable (depot) 2) Medically prescribed IUD; 3) condom in combination with a spermicide; 4) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. Birth control must have begun at least 3 months before the selection (except in the case of condoms in combination with spermicide), and the couple must agree to the continuation of the control for the duration of the study. Women of childbearing age who currently do not have an active sex life should have access to the use of contraceptive methods mentioned above, in case her sexual life is taken active while participating in the study. Those that were surgically sterilized or had no menstruation for at least one year will not be considered women of childbearing age.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically important asthma history 2. Subjects who abandoned the cigarette within 12 months prior to the Basal Period. 3. Subjects who have required a ventilator due to respiratory insufficiency in the last year. 4. Subjects with clinically significant disease in the lungs other than COPD, eg, bronchiectasis, sarcoidosis, pulmonary fibrosis, tuberculosis, etc. 5. Those who have had a lobectomy, pneumonectomy or surgery to reduce lung volume. 6. Subjects who have been diagnosed with lung cancer in the last 5 years or who have received treatment for lung cancer in the last 5 years. 7. Those who need continuous positive airway pressure (CPAP) or positive airway pressure in the two respiratory cycles (Bi-PAP) nasally. 8. Those who have started pulmonary rehabilitation within the last 3 months. 9. Those who use oxygen> 2 liters per minute for> 2 hours per day. 10. Subjects that require treatment with chronic or prophylactic antibiotics. 11. Subjects with a significant history of renal, hepatic, cardiovascular diseases (including cor pulmonale), metabolic neurological, hematological, gastrointestinal, cerebrovascular or other significant medical conditions or disorders that, in the opinion of the Investigator, may interfere with the study or require treatment that may affect the evaluation of the efficacy and safety of the study drug. 12. Those who present clinically significant abnormalities on chest radiographs (other than evidence of COPD) at the screening visit or within the previous year. 13. Women who are pregnant or breastfeeding. 14. Subjects that can’t comply with the restrictions and prohibitions of concomitant medications described in Section 3.4.3.1., Concomitant Medications and in Section 3.4.3.2., Prohibited Medications. 15. Those that have been previously randomized in this study. 16. Those that are directly related to the administration of the study. 17. Subjects with a history of allergic reaction or idiosyncrasy to corticosteroids. 18. Those who have received a research drug within 30 days prior to the selection. 19. Those who are not trained to use the MF-DPI device. 20. Subjects with evidence of oropharyngeal candidiasis in the Selection or in the Baseline Visit. 21. Subjects with a history of glaucoma or posterior sub-capsular cataract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary analysis of FEV1 and the total symptomatic score will be a longitudinal analysis model - random coefficient - including a random slope and an intercept for each patient. Smoking status and dose of steroids in the baseline visit (stratification factor), treatment, time, and treatment-by-smoker interactions and treatment-by-time will be the fixed effects included in the model. Cigarette consumption will be included in the model as a time-dependent covariate. This analysis will be complemented by the ANOVA model that extracts sources of variation due to the treatment, the smoking status and the consumption of cigarettes corresponding to each visit. The analysis of the percentage of subjects with one or more exacerbations will be based on the statistical blockade of Cochran-Mantel-Haenszel for the smoking status and the dose of steroids. If enough exacerbations are observed, survival analysis may be used to compare the mean time to the first exacerbation. The analysis will also consider potential prognostic factors such as sex, race, age, smoking status and cigarette consumption. Measure:1) the change in FEV1 after the administration of the bronchodilator, 2) the change in the total symptomatological score with respect to the baseline values and 3) the proportion of patients with one or more COPD exacerbations. Timepoints:Basal until 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:They will be analyzed using the same model of longitudinal analysis and the same modules per visit already described for FEV1. Measure:The secondary efficacy variables: other spirometry values (FEV1 before administration of the bronchodilator, FVC, and FEF 25-75% before and after the administration of the bronchodilator), the number of puffs of the rescue medication, the health-related quality of life (HRQOL), the six-minute walk distance and the Borg score. Timepoints:Basal until 52 weeks. (The quality of life related to health and the six-minute walk test will be measured at baseline and at 3, 6, 9 and 12 months.) | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed