CTRI/2011/07/001887CompletedPhase 2
A randomized, double-blind, placebo-controlled, Proof of Concept, study of 12 week treatment with RBx 10017609 in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
Ranbaxy Laboratories Limited12 sites in 1 country135 target enrollmentStarted: August 31, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ranbaxy Laboratories Limited
- Enrollment
- 135
- Locations
- 12
- Primary Endpoint
- To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD.
Study Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, two-arm, parallel group, comparative study. The study will be of 16 weeks duration consisting of 2 weeks of screening/run-in period followed by 12 weeks of treatment period and 2 weeks of safety follow-up period. The subjects will be randomized in a ratio of 2:1 to either of the two treatment arms: RBx 10017609 (200 mg BID) or placebo. The study medication will be administered with or without food twice daily (morning and evening) at an interval of approximately 12 hours. The study will involve 7 scheduled study visits to the study site [prescreening visit, screening/run-in visit (Day -14), randomization visit (Day 0), 2 (on therapy) visits (Day 28 and Day 56), end of treatment visit (Day 84) and safety follow-up visit (Day 98)]. Being a Global Study, approximately 108 Patients will be enrolled in India and approximately 27 patients will be enrolled in Estonia. All the 12 sites in India have sought Ethics Committee approval from the respective ethics Committees.
Estonia site details:
The name of 3 Investigators in Estonia are 1. Dr. Svetlana Sergejeva (West Tallinn Central Hospital (LTKH), Pelgulinna Hospital, Sõle 16, 10611, Tallinn, Estonia), 2. Dr. Kaiu Prikk (Lasnamäe Health Centre MEDICUM, Ltd, Punane 61, 13619 Tallinn, Estonia) 3. Dr. Erve Sõõru (Pulmonology Department, North Estonia Medical Centre, Foundation, 19 J. Sütiste Str, 13419 Tallinn, Estonia). The 3 sites in Estonia have sought Ethics Committee approval from Tallinn Medical Research Ethics Committee, Estonia. The tentative date of 1st patient enrollment is 31 August 2011.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria To be included in this study subjects must satisfy all inclusion and exclusion criteria at Visit 2 and prior to randomization at Visit 3, unless specified otherwise.
- •All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
- •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 to 75 years (both inclusive).
- •Female subjects should be of non-child bearing potential [post menopausal or those who have undergone surgical sterility (hysterectomy or bilateral tubal ligation or 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 Guidelines, 2009 and who additionally have a.Smoking history of at least 10 pack years (current and former smokers) b.Post bronchodilator FEV1 to FVC ratio of less than 0.70 at screening (Visit 2).
- •c.Post bronchodilator FEV1 of greater than or equal to 30 percent and less than or equal to 70 percent of the predicted normal value at screening.
- •Post bronchodilator refers to within 15 to 30 minutes of inhalation of 4 multiplied by100 mcg of salbutamol delivered at mouth piece (Visit 2).
- •Note: Menopause is defined as the time when there has been no menstrual period for 12 consecutive months and no other biological or physiological cause can be identified (diagnosed on the basis of age appropriateness and history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with FSH levels greater than 40 mIU per mL at screening.
- •Number of pack years that is (number of cigarettes or bidis smoked per day multiplied by number of years smoked) divided by 20.
Exclusion Criteria
- •Exclusion criteria 1.Subjects with history of hypersensitivity to study medication or drugs of similar class or beta 2 agonists or any of the excipients contained in any of these formulations.
- •2.Subjects with Body Mass Index of less than 18 or greater than 35 kg per meter square at screening (Visit 2).
- •3.Pregnant or nursing women or women of child bearing potential.
- •Note: Pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test (greater than 5 mIU per mL).
- •Note: All women who are physiologically capable of becoming pregnant.
- •4.Subjects having alpha 1 antitrypsin deficiency.
- •5.Subjects with history of asthma.
- •Note: History of asthma indicated by, but not limited to: (i) onset of respiratory symptoms suggestive of asthma prior to 40 years of age and (ii) a history of diagnosis of asthma.
- •If the subject had an absolute eosinophil count greater than or equal to 600 per cumm, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition 6.Subjects with active pulmonary tuberculosis, lung or any other malignancy, bronchiectasis, cystic fibrosis or pneumonia 7.Subjects using inhaled corticosteroids 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 or 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).
- •Note: Once stable, these subjects may be reconsidered for the study.
- •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 less than 88% on room air).
- •12.Subjects with significant disease(s), disorder(s) other than COPD that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
- •13.Subjects having arthritis or connective tissue disorder or any other joint disorder that in the opinion of the Investigator might interfere with the study evaluations 14.Subjects with history of consistent abnormal fasting blood sugar (greater than 250 mg per dl or 14 mmol per L) or HbA1c greater than 8percent at screening (Visit 2).
- •15.Subjects with family history of long QT syndrome.
- •16.Subjects with clinically significant abnormal 12 lead ECG or QTc greater than 450 milliseconds as calculated by Fridericia formula.
- •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) greater than 2 times ULN or total bilirubin or serum creatinine greater than 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 greater than 21 units for males and greater than 14 units for females.
- •Note: 1 unit i.e. 284 mL of beer; 25 mL of spirits or 125 mL of wine 23.Subjects with history of drug abuse.
- •24.Subjects who have received live attenuated vaccination within 4 weeks prior to screening (Visit 2).
- •Note: The use of polysaccharide pneumococcal and hemophilus influenzae vaccines is permitted.
- •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 participating in another study.
- •27.Subjects who, in the opinion of the Investigator, are unable to perform spirometry or sputum induction procedures or complete the St George Respiratory Questionnaire.
Outcomes
Primary Outcomes
To assess the safety and tolerability of 12 week treatment with RBx 10017609 (200 mg BID) in subjects with moderate to severe COPD.
Time Frame: At the end of 12 week
Secondary Outcomes
- Assess efficacy of RBx10017609 wrt change in the following parameters as compared to placebo(1)Sputum neutrophil count)
Investigators
Study Sites (12)
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