Back to resultsA Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Roflumilast
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring roflumilast
Eligibility Criteria
Inclusion Criteria:
- Is male or female and aged 40 or olderThe BMI≥ 19.0 kg/m2;
- The patient with severe to very severe COPD as difine by the 2015 Gold strategy .(postbronchodilator ≤0.7,，and a postbronchodilator FEV1≤50% predicted);
- Has a history of chronic obstructive pulmonary disease (COPD) (according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015) for at least 12 months prior to Screening (Visit V0), At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 0);
- Must be a former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years;
- Women of childbearing age must take reliable contraceptive measures
- Signed informed consent
Exclusion Criteria:
- Severe or very severe COPD exacerbations is still exist in screen visit(V0);
- Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0;
- History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD;
- relevant lung disease other than COPD,as: Bronchiectasis, Cystic fibrosis, capillary bronchitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis
- Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
- Known alpha-1-antitrypsin deficiency;
- Clinically significant abnormal Laboratory examination,may due to one Undiagnosed disease
- The patient with severe Mental or neurological disease;
- Has a history with Suicidal ideation or depression;
- Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade III-IV;
- Used disabled combination medicine;
- A serious autoimmune disease;
- Liver dysfunction according to Child-Pugh B/C;
- Serious acute Infectious diseases;
- Has a history Malignant in the last 5 years;
Sites / Locations
- First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
roflumilast:250μg
roflumilast:375μg
roflumilast:500μg
placebo
Arm Description
Drug: Roflumilast Roflumilast tablets Roflumilast 250 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Drug: Roflumilast Roflumilast tablets Roflumilast 375 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Drug: Roflumilast Roflumilast tablets Roflumilast 500 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Drug: placebo placebo tablets placebo tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Outcomes
Primary Outcome Measures
Area under the plasma concentrationafter versus drug dose
Secondary Outcome Measures
Percentage of Participants with Adverse Events of Interest
Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.
Change in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) during the down titration period
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing will be performed using spirometry prior to taking study medication
Full Information
NCT ID
NCT02671942
First Posted
January 25, 2016
Last Updated
May 20, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02671942
Brief Title
A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
March 2016 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient.
Detailed Description
Roflumilast is a product which has been approved for the treatment of severe chronic obstructive lung disease (COPD) and its approved dose is 500μg once daily. This study is primarily designed to see whether alternation in this dose can improve tolerability of Roflumilast in COPD patients. Therefore one in three patients will start roflumilast therapy at a lower dose of 250μg/375μg once daily, another one in three will only take the 500μg tablet every day (and one placebo every day). Furthermore, the study will evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient.
Lastly, the study will investigate what the body does to roflumilast. Patients with a history of COPD for at least last 12 months and a former smoker or current smoker with history of at least 10 pack years will be invited to participate.
The Randomization visit is considered the Baseline visit and for participants that discontinue the Main Period and continue into the Down-Titration Period Day 1 of Down Titration is considered BaselineDT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
roflumilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
roflumilast:250μg
Arm Type
Active Comparator
Arm Description
Drug: Roflumilast Roflumilast tablets Roflumilast 250 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Arm Title
roflumilast:375μg
Arm Type
Active Comparator
Arm Description
Drug: Roflumilast Roflumilast tablets Roflumilast 375 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Arm Title
roflumilast:500μg
Arm Type
Active Comparator
Arm Description
Drug: Roflumilast Roflumilast tablets Roflumilast 500 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Drug: placebo placebo tablets placebo tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Area under the plasma concentrationafter versus drug dose
Time Frame
baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events of Interest
Description
Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.
Time Frame
baseline to 12 weeks
Title
Change in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) during the down titration period
Description
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing will be performed using spirometry prior to taking study medication
Time Frame
baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is male or female and aged 40 or olderThe BMI≥ 19.0 kg/m2;
The patient with severe to very severe COPD as difine by the 2015 Gold strategy .(postbronchodilator ≤0.7,，and a postbronchodilator FEV1≤50% predicted);
Has a history of chronic obstructive pulmonary disease (COPD) (according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015) for at least 12 months prior to Screening (Visit V0), At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 0);
Must be a former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years;
Women of childbearing age must take reliable contraceptive measures
Signed informed consent
Exclusion Criteria:
Severe or very severe COPD exacerbations is still exist in screen visit(V0);
Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0;
History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD;
relevant lung disease other than COPD,as: Bronchiectasis, Cystic fibrosis, capillary bronchitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis
Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
Known alpha-1-antitrypsin deficiency;
Clinically significant abnormal Laboratory examination,may due to one Undiagnosed disease
The patient with severe Mental or neurological disease;
Has a history with Suicidal ideation or depression;
Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade III-IV;
Used disabled combination medicine;
A serious autoimmune disease;
Liver dysfunction according to Child-Pugh B/C;
Serious acute Infectious diseases;
Has a history Malignant in the last 5 years;
Facility Information:
Facility Name
First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Have no plan to make individual participant data available.
Learn more about this trial
A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients
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