Acute COPD exacerbations MedDRA version: 14.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: BCT197
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BCT197
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the p
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any study related assessment is performed. 2. Males/females age = 40 to = 80 years 3. COPD diagnosed according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2009) as Stage II to IV and patient presenting with a COPD exacerbation 4. Smoking history of at least 10 pack years 5. Females must NOT be of child bearing potential (post-menopausal [according to protocol definition] or surgically sterilized). All female patients must have a negative pregnancy test result before randomization. 6. Be able to communicate well with the investigator, be able to understand and comply with the requirements of the study, and be able to perform acceptable spirometry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 61 ;Inclusion criteria: 1. Written informed consent must be obtained before any study related assessment is performed. 2. Males/females age = 40 to = 80 years 3. COPD diagnosed according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2009) as Stage II to IV and patient presenting with a COPD exacerbation 4. Smoking history of at least 10 pack years 5. Females must NOT be of child bearing potential (post-menopausal [according to protocol definition] or surgically sterilized). All female patients must have a negative pregnancy test result before randomization. 6. Be able to communicate well with the investigator, be able to understand and comply with the requirements of the study, and be able to perform acceptable spirometry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 61
Exclusion criteria
Exclusion criteria: 1.Use of any oral or iv corticosteroids within 30 days of randomization 2.Use of any calcium channel blockers within 48 hours of randomization 3.Use of macrolide containing antibiotics within 48 hours of randomization 4.Arterial blood pH 15 hours a day) 15.History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) as judged clinically significant by the attending physician. 16.History of immunodeficiency diseases. 17.History of Hepatitis B or C. 18.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted at baseline. 19.Fertile males defined as all males physiologically capable of conceiving offspring UNLESS the patient agrees to one of the criteria below (for 10 days following study drug administration i.e.: for Days 1 to 10 inclusive in Part I & II, and for Days 1 to 20 inclusive in Parts III and IV) a) Use two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap) plus spermicide, if sexually active OR b) To be abstemious ;Exclusion criteria: 1.Use of any oral or iv corticosteroids within 30 days of randomization 2.Use of any calcium channel blockers within 48 hours of randomization 3.Use of macrolide containing antibiotics within 48 hours of randomization 4.Arterial blood pH 15 hours a day) 15.History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) as judged clinically significant by the attending physician. 16.History of immunodeficiency diseases. 17.History of Hepatitis B or C. 18.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted at baseline. 19.Fertile males defined as all males physiologically capable of conceiving offspring UNLESS the patient agrees to one of the criteria below (for 10 days following study drug administration i.e.: for Days 1 to 10 inclusive in Part I & II, and for Days 1 to 20 inclusive in Parts III and IV) a) Use two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap) plus spermicide, if sexually active OR b) To be abstemious
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the efficacy of a single and repeated dose of BCT197 in COPD patients presenting with an exacerbation measured by the improvement in FEV1 over the first 5 days of treatment relative to placebo, and over the first 10 days in Parts III and IV.;Secondary Objective: • To assess the safety & tolerability of a single and a repeated dose of BCT197 in this patient population • To measure the time to recovery using the EXACT-PRO 14 point patient reported outcome • To assess the time to the next exacerbation during the follow-up period • To assess the proportion of patients responding to treatment with BCT197 at Day 30 • To assess dyspnea as measured by the Borg CR10 scale® at Day 5, as compared to baseline • To assess Quality of Life as measured by SAS/IAS CRQ patient reported outcome at Day 14 • To assess length of hospitalization following initial admission (if appropriate – not all patients will be admitted) • To determine the pharmacokinetics of BCT197 and its metabolites in plasma following a single (Day 1) and a two day dose (Day 1 & Day 6);Primary end point(s): The improvement in FEV1 over the first 5 days of treatment relative to placebo. Measure: FEV1, in Parts I and II, and improvement in FEV1 over the first 10 days in Parts III and IV. ;Timepoint(s) of evaluation of this end point: Day 5 for parts I and II Day 10 for parts III and IV;Main Objective: • To assess the efficacy of a single and repeated dose of BCT197 in COPD patients presenting with an exacerbation measured by the improvement in FEV1 over the first 5 days of treatment relative to placebo, and over the first 10 days in Parts III and IV.;Secondary Objective: • To assess the safety & tolerability of a single and a repeated dose of BCT197 in this patient population • To measure the time to recovery using the EXACT-PRO 14 point patient reported outcome • To assess the time to the next exacerbation during the follow-up period • To assess the proportion of patients responding t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to recovery using the EXACT-PRO 14 point patient reported outcome;Timepoint(s) of evaluation of this end point: days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 30;Secondary end point(s): Time to recovery using the EXACT-PRO 14 point patient reported outcome;Timepoint(s) of evaluation of this end point: days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, 30 | — |
Countries
Bulgaria, Romania, Russian Federation
Contacts
Public Contact; ;
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Outcome results
None listed