A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:

NCT01313494 | Completed Phase 3 Results

• 2 other identifiers: RO-2455-301-RDU1111-1133-6304
• Study Type: interventional
• Target: 626
• Locations: 3 countries
• Sites: 15

Brief Summary

The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.

Conditions

COPD

Keywords

COPD; Roflumilast; FEV1; China

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)

  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 was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.

  Baseline to Week 24

Secondary Outcomes (23)

• Change From Baseline in Post-bronchodilator FEV1

  Baseline to Week 24

• Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)

  Baseline to Week 24

• Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)

  Baseline to Week 24

• Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%

  Baseline to Week 24

• Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%

  Baseline to Week 24

Study Arms (2)

Roflumilast

EXPERIMENTAL

Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.

Drug: Roflumilast; Drug: Salbutamol

Placebo

PLACEBO COMPARATOR

Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.

Drug: Placebo; Drug: Salbutamol

Interventions

Roflumilast DRUG

Roflumilast tablets

Roflumilast

Placebo DRUG

Placebo tablets

Placebo

Salbutamol DRUG

Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.

Placebo; Roflumilast

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign a written informed consent
• Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
• Chinese or Malay or Indian ethnicity
• History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
• Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) \< 70%
• Forced expiratory volume in the first second (FEV1) (post-bronchodilator) \< 50 % of predicted
• 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

You may not qualify if:

• Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at 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
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (15)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changsha, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Nanning, China

Location

Unknown Facility

Qingdao, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Shijiazhuang, China

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Singapore, Singapore

Location

Related Publications (1)

• Zheng J, Yang J, Zhou X, Zhao L, Hui F, Wang H, Bai C, Chen P, Li H, Kang J, Brose M, Richard F, Goehring UM, Zhong N. Roflumilast for the treatment of COPD in an Asian population: a randomized, double-blind, parallel-group study. Chest. 2014 Jan;145(1):44-52. doi: 10.1378/chest.13-1252.

  PMID: 24135893 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 1, 2017
• Results First Posted: August 2, 2013

Record last verified: 2016-09

Locations

CN (13); HK (1); SG (1)