Moderate to severe chronic obstructive pulmonary disease.
Conditions
Interventions
Product Name: RBx 10017609
Product Code: RBx 10017609
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Ranbaxy Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have signed an informed consent consistent with ICH-GCP guidelines prior to participation in the trial at prescreening visit. 2. Male or female subjects, aged =40 years. Female subjects should be of non-childbearing potential [post menopausal* or those who have undergone surgical sterility (hysterectomy/bilateral tubal ligation/ bilateral oophorectomy)]. Sexually active male subjects should agree to use a medically accepted form of contraception (barrier method) or must have undergone vasectomy in the past and their partner should be either using a medically acceptable form of contraception (oral contraceptives, intrauterine contraceptive devices) or have undergone tubal ligation in the past. 3. Subjects with clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009 and who additionally have: - smoking history of at least 10 pack years** (current and former smokers) - post-bronchodilator FEV1 to FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with history of hypersensitivity to study medication / drugs of similar class or ß2-agonists or any of the excipients contained in any of these formulations. 2. Subjects with Body Mass Index (BMI) of 35 kg/m2 at screening (Visit 2). 3. Pregnant* or nursing women or women of child bearing potential**. 4. Subjects having alpha-1 antitrypsin deficiency. 5. Subjects with history of asthma***. 6. Subjects with active pulmonary tuberculosis, lung or any other malignancy, bronchiectasis, cystic fibrosis or pneumonia 7. Subjects using inhaled corticosteroids (ICS) and unable to stop these during the screening/run-in period. 8. Subjects who have received treatment with oral or parenteral glucocorticosteroids within 6 weeks of screening/run-in period or depot corticosteroids within 12 weeks of screening/run-in period. 9. Subjects with history of COPD exacerbation requiring systemic glucocorticosteroids and/or antibiotics and/or hospitalization within 6 weeks of screening****(Visit 2). 10. Subjects with history of respiratory tract infection within 6 weeks of screening visit (Visit 2). Subjects who develop a respiratory tract infection between pre-screening (Visit 1) and randomization (Visit 3) must discontinue from the trial but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met. 11. Subjects with hypoxemia (SpO2 250 mg/dl or 14 mmol/L) or HbA1c greater than 8% at screening (Visit 2). 15. Subjects with family history of long QT syndrome. 16. Subjects with clinically significant abnormal 12-lead ECG or QTc >450 milliseconds as calculated by Fridericia formula (QTc = QT/RR0.33). 17. Subjects with history of any lung surgery (e.g., lung resection etc.). 18. Subjects with conditions which, in the opinion of the Investigator, prevent subjects from performing spirometry (e.g., hemoptysis of unknown origin, recent eye surgery etc.). 19. Subjects requiring assisted ventilation or subjects who regularly use daytime oxygen therapy for more than 1 hour per day. 20. Subjects with clinically significant abnormal haematology, biochemistry, or urinalysis; all subjects with an SGOT (AST) or SGPT (ALT) >2 times ULN or total bilirubin or serum creatinine >1.2 times ULN (Visit 2). 21. Subjects with a history of HIV or positive serology results for Hepatitis B or C in the past 3 months prior to screening (Visit 2). 22. Subjects with history of habitual alcohol consumption exceeding an average weekly intake of >21 units for males and >14 units for females***** . 23. Subjects with history of drug abuse. 24. Subjects who have received live attenuated vaccination within 4 weeks prior to screening****** (Visit 2). 25. Subjects who have received any other investigational drug within the last 3 months of screening visit (Visit 2). 26. Subjects who have previously been randomized in this study or are currently parti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD. ;Secondary Objective: • To assess the efficacy of 12 week treatment with RBx 10017609 (200 mg BID) with respect to change in the following parameters as compared to placebo in subjects with moderate to severe COPD: - Sputum neutrophil count (percentage) - FEV1 - St. George’s Respiratory Questionnaire (SGRQ) ;Primary end point(s): • To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD. | — |
Countries
Estonia, Greece
Outcome results
None listed