Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Randomized Double-blind Clinical Study Evaluated the Safety, Pharmacokinetic and Pharmacodynamic Characteristics of Roflumilast in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671942
Recruitment Status : Terminated
First Posted : February 2, 2016
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Roflumilast Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 13, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arm Intervention/treatment
Active Comparator: roflumilast:250μg
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
Active Comparator: roflumilast:375μg
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
Active Comparator: roflumilast:500μg
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: Roflumilast
Placebo Comparator: placebo
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
Drug: Placebo



Primary Outcome Measures :
  1. Area under the plasma concentrationafter versus drug dose [ Time Frame: baseline to 8 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events of Interest [ Time Frame: baseline to 12 weeks ]
    Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.

  2. Change in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) during the down titration period [ Time Frame: baseline to 12 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is male or female and aged 40 or olderThe BMI≥ 19.0 kg/m2;
  2. The patient with severe to very severe COPD as difine by the 2015 Gold strategy .(postbronchodilator ≤0.7,,and a postbronchodilator FEV1≤50% predicted);
  3. 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);
  4. 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;
  5. Women of childbearing age must take reliable contraceptive measures
  6. Signed informed consent

Exclusion Criteria:

  1. Severe or very severe COPD exacerbations is still exist in screen visit(V0);
  2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0;
  3. History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD;
  4. relevant lung disease other than COPD,as: Bronchiectasis, Cystic fibrosis, capillary bronchitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis
  5. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
  6. Known alpha-1-antitrypsin deficiency;
  7. Clinically significant abnormal Laboratory examination,may due to one Undiagnosed disease
  8. The patient with severe Mental or neurological disease;
  9. Has a history with Suicidal ideation or depression;
  10. Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade III-IV;
  11. Used disabled combination medicine;
  12. A serious autoimmune disease;
  13. Liver dysfunction according to Child-Pugh B/C;
  14. Serious acute Infectious diseases;
  15. Has a history Malignant in the last 5 years;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671942


Locations
Layout table for location information
China, Guangdong
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Layout table for additonal information
Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT02671942    
Other Study ID Numbers: CTTQ-01459-IIA
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Have no plan to make individual participant data available.
Keywords provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.:
roflumilast
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases