STUDY ON THE EFFICACY AND SAFETY OF MOMETHASONE FUROATE IN DRY POWDER INHALER IN THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Not Applicable

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

• Registration Number: PER-029-01
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The subjects must be 40 years of age and older and can be of both sexes and any race.
• Subjects must have a clinical history of COPD
• Subjects must be current smokers or ex-smokers who have quit smoking at least one year before the start, subjects must have a history of at least 10-year-old smokers. The years-tied are calculated by multiplying the average of the bundles of cigarettes consumed per day by the years of consumption.
• The subjects must present a pre-bronchodilator FEV1 / FVC ratio <70%, both in the Pre-selection visit and in the Selection and Home Visits
• After four applications of Proventil administered by means of an MDI with a spacer, the subjects must present, in the Pre-selection, Selection and Start, a reversibility in FEV1 <10% of projected FEV1
• Subjects must present a post-bronchodilator FEVi <70% of the projected normal and> 25%
• Subjects must present in the Selection, clinical laboratory analysis (complete blood count, blood chemistry and urinalysis) whose results are within normal values ​​or are clinically acceptable to the Investigator / Sponsor.
• Subjects must be willing to give informed consent in writing and must be able to comply with dose and visit schedules.
• Subjects must agree to inform their GP about their participation in this study.
• Women who are not pregnant and who can conceive should be using an adequate and medically acceptable method of contraception. These methods include: 1) hormonal contraceptive prescribed by a doctor (eg combined oral, hormonal implant, depot injectable): 2) IUD prescribed by a doctor; 3) condom in combination with a spermicide; and 4) monogamous relationship with a male partner who has undergone a vasectomy or who uses a more spermicidal condom during the entire study. They must have started using this contraceptive method at least 3 months before the Selection (with the exception of the condom in combination with a spermicide), and they must agree to continue using it during the course of the study. Women who can conceive but do not currently have sexual intercourse should agree to use a double-barrier method if they begin to have an active sex life during the course of the study. Women who have undergone surgical sterilization or who have been at least one year since their menopause are not considered to be women able to conceive.

Exclusion Criteria

• Subjects with a history of clinically relevant asthma.
• Subjects who quit smoking within 12 months prior to Start.
• Subjects who have required support with a respirator due to respiratory failure within the last year.
• Subjects with clinically significant lung disease other than COPD, p. eg, bronchiectasis, sarcoidosis, pulmonary fibrosis, tuberculosis, etc.
• Subjects who have undergone a lobectomy, pneumonectomy or surgery to reduce lung volume.
• Subjects who have been diagnosed with lung cancer, or who have received treatment for lung cancer, within the last five years.
• Subjects requiring continuous positive airway pressure (CPAP) through nasal or positive airway pressure in the two respiratory cycles (Bi-PAP).
• Subjects who have started pulmonary rehabilitation within the last 3 months.
• Subjects that use more than 2 liters of oxygen per minute for more than 2 hours per day.
• Subjects who have received oral, inhaled or parenteral corticosteroids in the six weeks prior to the Selection.
• Subjects that require treatment with chronic or prophylactic antibiotics.
• Subjects with a significant history of kidney, liver, cardiovascular (including cor pulmonale), metabolic, neurological, hematological, gastrointestinal, or cerebrovascular diseases or disorders or a history of any other significant medical condition or disorder that, in the opinion of the Investigator, could interfere with the study or require treatment that could affect the evaluation of the effectiveness and safety of the study drug.
• Subjects who present clinically significant abnormalities on chest radiography (other than evidence of COPD) at the Screening visit or within the previous 12 months.
• Pregnant women or those who are breastfeeding.
• Subjects who can not comply with the restrictions and prohibitions regarding concomitant medications
• Subjects that have been randomized to this study before.
• Subjects directly related to the administration of this study.
• Subjects with a history of allergic or idiosyncratic reaction to corticosteroids.
• Subjects that can not use the MF-DPI device.
• Subjects with evidence of oropharyngeal candidiasis in the selection or onset.
• Subjects with chronic open-angle glaucoma or posterior subcapsular cataract (patients who have had their cataract removed by surgery may participate in the study).
• Smokers with evidence of disorders of the temporomandibular joint.
• Subjects that between the Selection and the Home comply with less than 80% of the record of the information of the newspapers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Spirometry before and after the bronchodilator<br>Measure:The modification produced with respect to the Start in FEV1 after the administration of the bronchodilator<br>Timepoints:Subsequent to the administration of the bronchodilator<br>;<br>Outcome name:The total COPD symptom score of each day will be the average of the morning and evening total morning symptoms of the COPD symptoms of the day in question.<br>Measure:The modification produced in the total rating of COPD symptoms with respect to the Start<br>Timepoints:At the beginning and at the end of treatment<br>;<br>Outcome name:The analysis of the percentage of subjects with one or more exacerbations will be based on the Cochran-Mantel-Haenszel block statistics for smoking / non-smoking status.<br>Measure:The percentage of subjects with one or more COPD exacerbations.<br>Timepoints:At the end of the treatment<br>