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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02671942
• Other study ID #: CTTQ-01459-IIA
• Status: Terminated
• Phase: Phase 2
• 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
• 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;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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