Health Condition 1: null- Adult Patients with Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: Roflumilast: 0.5 mg tablet once daily for 24 weeks
Control Intervention1: SEROBID® [Salmeterol]: Two inhalations of 25 mcg each, twice daily (total dose 100 mcg per day) for 24 weeks
C
Sponsors
MSN Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male or female patients aged 35-65 years. 2)Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits and compliance with protocol requirements as evidenced by providing written informed consent 3)COPD patients having at least one documented moderate or severe exacerbation within one year prior to baseline visit. 4)FEV1 5)FEV1/FVC ratio 6)Patients already on therapy for COPD with beta2 adrenergic receptor agonists / muscarinic receptor antagonists / Xanthine class of drugs. 7)Presence of respiratory symptoms of COPD including dyspnea, cough and sputum production. 8)Current smokers or patients with a history of smoking. 9)For women of child-bearing potential: women is not pregnant (and has to undergo urine pregnancy test at the time of screening which must be negative) and not nursing, and is practicing an acceptable method of birth control.
Exclusion criteria
Exclusion criteria: 1)Inability to adequately perform spirometry. 2)COPD exacerbation indicated by a treatment with systemic corticosteroids and/or antibiotics not stopped within 4 weeks prior to screening visit and remains uncontrolled in between the treatment periods. 3)Diagnosis of asthma and/or other relevant lung disease. 4)Suffering from any concomitant disease that might interfere with study procedures or evaluation. 5)Lower respiratory tract infection not resolved 4 weeks prior to the screening visit. 6)Known clinically significant cardiopulmonary abnormalities (diagnosed clinically or documented by X-ray or ECG) and are not related to COPD and that require further evaluation. 7)Known case of HIV and/or patient currently on cytotoxic drugs. 8)Hepatitis and/or liver insufficiency (SGOT and/or SGPT >= 5 times the upper limit of the normal reference range) 9)Renal insufficiency (S. Creatinine >= 5 times the upper limit of the normal reference range) 10)Known or suspected hypersensitivity to the study drug or its components. 11)Known or suspected hypersensitivity to milk-proteins. 12)Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial. 13)History of, or known current problem with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patients participation in the study, or with evaluation of the study results. 14)Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures. 15)Have any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety of the study drug according to the study protocol (e.g., poorly compliant subject).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Mean change in the pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between the treatment arms 2)Mean change in the post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between the treatment armsTimepoint: From baseline visit to end of the therapy i.e. Week 24±2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of clinical laboratory parametersTimepoint: At visit 1 (baseline) and visit 7 (end of therapy);Changes in the mean FEV1/FVC ratio between the treatment armsTimepoint: From baseline to end of the therapy i.e. Week 24±2 days;General examination and assessment of vital signs.Timepoint: At every visit;Mean change in the reduction of COPD exacerbations between the treatment armsTimepoint: From baseline visit to each post randomization visit;Percentage of the subjects reporting AE and/or ADR. Timepoint: At visit 2, 3, 4, 5, 6 and 7 | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed