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

NCT02671942 | Terminated Phase 2

• 1 other identifier: CTTQ-01459-IIA
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

roflumilast

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentrationafter versus drug dose

  baseline to 8 weeks

Secondary Outcomes (2)

• Percentage of Participants with Adverse Events of Interest

  baseline to 12 weeks

• Change in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) during the down titration period

  baseline to 12 weeks

Study Arms (4)

roflumilast:250μg

ACTIVE COMPARATOR

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:375μg

ACTIVE COMPARATOR

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:500μg

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Interventions

Roflumilast DRUG

roflumilast:250μg; roflumilast:375μg; roflumilast:500μg

Placebo DRUG

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 2, 2016
• Study Start: March 1, 2016
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)