A randomized, open labelled, multi centric parallel group three arms clinical study to evaluate the effifacy and safety of roflumilast 500mcg tablet in chronic obstructive pulmonary disorder.

Phase 3

• Conditions: Chronic Obstructive Pulmonary Disorder with mild, moderate and Severe Condition.

• Registration Number: CTRI/2012/09/002961
• Lead Sponsor: Glenmark Generics Limited

Brief Summary

A Phase 3, Prospective, randomized open labelled multicentric parallel group three arms clinical study to evaluate the efficacy and safety between monotherapy of GLenmark’s Roflumilast 500mcg tablet and combination therapy of ROflumilast 500mcg tablet plus Salmeterol 25mcg inhalation in Adults patients with Chronic Obstructive Pulmonary Disorder.

The Primary outcome measure is to assess the efficacy and safety between the monotherapy of ROflumilast 500mcg tablet tablet and combination therapy of ROflumilast 500mcg tablet plus salmeterol 25mcg inhalation in Adult patents with Chronic Obstructive Pulmonary Disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 1.Male or Female patients. 2.Age ≥ 40 years and < 65 years. 3.Written Informed Consent 4.Patients diagnosed with COPD, confirmed by spirometry test at screening visit with the following lung function parameters.
• •FEV1 (post-bronchodilator) between ≥ 30% and < 80% • FEV1/FVC ratio (post-bronchodilator) < 70% 5.Patients with background therapy for COPD like beta 2 adrenergic receptor agonists / muscarinic receptor antagonists / Xanthine class of drugs 6.Patients with background therapy of inhaled corticosteroids who on a stable dose since last 6 weeks without any COPD exacerbations requiring treatment with systemic corticosteroids and hospitalization; will continue to use the same dose of inhaled corticosteroids during the complete study period. 7.Patients who are on ongoing concomitant therapy of Salbutamol inhaler will continue the medication through out the study period on SOS basis (i.e. up to 8 inhalations / day with a dose of 100mcg / inhalation). Salbutmaol inhalation therapy will be added for use as rescue medication on SOS basis to those patients who do not have prescribed Salbutamol inhalation therapy. 8.Current smokers with a smoking history of < 10 pack years or ex-smokers (smoking cessation at least one year ago) 9. Females of child bearing age must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study and at least 1 weeks post treatment if they are sexually active.

Exclusion Criteria

• 1.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.
• 2.Diagnosis of asthma and/or other relevant lung disease.
• 3.Suffering from any concomitant disease that might interfere with study procedures or evaluation.
• 4.Lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
• 5.Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation.
• 6.Known infection with HIV, active hepatitis and/or liver insufficiency.
• 7.Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start.
• 8.Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial.
• 9.Participation in another study (use of investigational product) within 30 days preceding the screening visit or re-entry of patients already enrolled in this trial.
• 10.Suspected inability or unwillingness to comply with study procedures.
• 11.Alcoholic or having drug abuse.
• 12.Inability to follow study procedures due to, for example, language problems or psychological disorders.
• 13.Use of prohibited medications like systemic corticosteroids, short acting beta 2 adrenergic receptor agonist except Salbutamol, long acting beta 2 adrenergic receptor agonist except Salmeterol, short or long-acting muscarinic antagonist except tiotropium, any other fixed dose combinations of inhaled medicines used for COPD and Xanthine class of drugs post randomization visit throughout the study period.
• 14.Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast/ salmeterol/ tiotropium) or salbutamol rescue medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean change in pre bronchodilator Forced Expiratory Volume in 1 second (FEV1) [as measured in the clinic/hospital by trained personnel] between the treatment arms from the baseline visit at the End of study (Week 24) and mean change in reduction of COPD exacerbations between the treatment arms from baseline visit at each post randomization visit [as measured from the patient dairy data in the clinic/hospital by trained personnel].	FEV1 at baseline visit 1 and at week 24 (end of study)

Secondary Outcome Measures

Name	Time	Method
1.Changes in Mean Forced Vital Capacity from randomization visit to each post randomization study visit during the treatment period obtained by the spirometry test.	2.Changes in Mean FEV1/ FVC ratio from randomization visit to each post randomization study visit during the treatment period obtained by the spirometry test.

Trial Locations

Locations (17)

Asthma Bhawan; 🇮🇳 Jaipur, RAJASTHAN, India

Bhatia Hospital, Medical Research Society; 🇮🇳 Mumbai, MAHARASHTRA, India

C.S.M. Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Department Dept. Pulmonary Medicine; 🇮🇳 Mumbai, MAHARASHTRA, India

Dept. Of Medcine, GMERS Medical College; 🇮🇳 Vadodara, GUJARAT, India

Dept. Of Respiratory, KLES Dr. Prabhakar Kore Hospital and Medical Research Center; 🇮🇳 Belgaum, KARNATAKA, India

Ethika Cinical Research center, Prakruti Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Krishna Hospital; 🇮🇳 Pune, MAHARASHTRA, India

National Allergy Asthma Bronchitis Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Nobel Hospital; 🇮🇳 Pune, MAHARASHTRA, India

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Asthma Bhawan

🇮🇳Jaipur, RAJASTHAN, India

Dr Ashish Kumar

Principal investigator

9314249227

drashish19@gmail.com