Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02671942
Other study ID # CTTQ-01459-IIA
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date June 13, 2018

Study information

Verified date May 2019
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 55
Est. completion date June 13, 2018
Est. primary completion date June 13, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Roflumilast

Placebo


Locations

Country Name City State
China First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentrationafter versus drug dose baseline to 8 weeks
Secondary 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. baseline to 12 weeks
Secondary 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 baseline to 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy