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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:
NCT01313494
First received: March 3, 2011
Last updated: August 18, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
COPD
 Drug: Roflumilast
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 6-month, Double-blind, Randomised, Multicenter, Multinational Trial to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With COPD. The ACROSS Trial

Resource links provided by NLM:

Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]
    Change from baseline over 24 weeks of treatment in pre-bronchodilator FEV1


Secondary Outcome Measures:
  • Post-bronchodilator FEV1 [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]
    Change from baseline over 24 weeks of treatment in post-bronchodilator FEV1

  • Change in frequency of daily cough and sputum production [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]
    Symptoms of chronic bronchitis with respect to frequency of cough and sputum production will be assessed on a daily basis by the patient.

  • Rate of COPD exacerbations per patient [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as measure of safety and tolerability [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 626
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roflumilast Drug: Roflumilast
500 μg, tablet, oral, once daily
Placebo Comparator: Placebo Drug: Placebo
Placebo tablet, oral, once daily

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Willingness to sign a written informed consent
  • Chronic obstructive pulmonary disease according to 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
  • FEV1/FVC ratio (post-bronchodilator) < 70%
  • 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

Main Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313494

Locations
China
Nycomed Investigational Site
Beijing, China
Nycomed Investigational Site
Changsha, China
Nycomed Investigational Site
Chengdu, China
Nycomed Investigational Site
Chongqing, China
Nycomed Investigational Site
Fuzhou, China
Nycomed Investigational Site
Guangzhou, China
Nycomed Investigational Site
Hangzhou, China
Nycomed Investigational Site
Nanjing, China
Nycomed Investigational Site
Nanning, China
Nycomed Investigational Site
Qingdao, China
Shanghai, China
Nycomed Investigational Site
Shenyang, China
Nycomed Investigational Site
Shijiazhuang, China
Hong Kong
Nycomed Investigational Site
Hong Kong, Hong Kong
Singapore
Nycomed Investigational Site
Singapore, Singapore
Sponsors and Collaborators
Nycomed: A Takeda Company
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier: NCT01313494     History of Changes
Other Study ID Numbers: RO-2455-301-RD, U1111-1133-6304
Study First Received: March 3, 2011
Last Updated: August 18, 2012
Health Authority: China: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Health Sciences Authority

Keywords provided by Takeda Global Research & Development Center, Inc.:
COPD
Roflumilast
FEV1
China

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013