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

Tracking Information
First Received Date ^ICMJE	March 3, 2011
Last Updated Date	August 18, 2012
Start Date ^ICMJE	September 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 10, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01313494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 10, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore: The ACROSS Trial
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	COPD
Intervention ^ICMJE	Drug: Roflumilast 500 μg, tablet, oral, once daily Drug: Placebo Placebo tablet, oral, once daily
Study Arm (s)	Active Comparator: Roflumilast Intervention: Drug: Roflumilast Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	626
Completion Date	May 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China, Hong Kong, Singapore

Administrative Information
NCT Number ^ICMJE	NCT01313494
Other Study ID Numbers ^ICMJE	RO-2455-301-RD, U1111-1133-6304
Has Data Monitoring Committee	Not Provided
Responsible Party	Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
Study Sponsor ^ICMJE	Nycomed: A Takeda Company
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Takeda Global Research & Development Center, Inc.
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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