Clinical trial NCT01313494: A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: COPD
Roflumilast
FEV1
China
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 626
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline in Post-bronchodilator FEV1
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%
timeFrame: Baseline to Week 24
measure: Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF)
timeFrame: Baseline to Week 24
measure: Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity
timeFrame: Baseline and Week 24
measure: Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity
timeFrame: Baseline and Week 24
measure: Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds
timeFrame: Baseline and Week 24
measure: Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds
timeFrame: Baseline and Week 24
measure: Change From Baseline in COPD Symptom Scores
timeFrame: Baseline to Week 24
measure: Change From Baseline in Use of Rescue Medication
timeFrame: Baseline to Week 24
measure: Transition Dyspnoea Index (TDI) Total Score at Week 24
timeFrame: Baseline to Week 24
measure: Percentage of Participants With Moderate or Severe COPD Exacerbations
timeFrame: 24 weeks
measure: Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year
timeFrame: 24 weeks
measure: Time to Onset of First Moderate or Severe COPD Exacerbation
timeFrame: 24 weeks
measure: Time to Onset of Second Moderate or Severe COPD Exacerbation
timeFrame: 24 weeks
measure: Number of Participants With Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Nanning
country: China
city: Qingdao
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Shijiazhuang
country: China
city: Hong Kong
country: Hong Kong
city: Singapore
country: Singapore
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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.