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

Sponsor
AstraZeneca
Study ID
NCT01313494
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast tablets
  • Placebo — DRUG
    Placebo tablets
  • 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.

Study Details

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.

Key Dates

Start date
Mar 31, 2011
Status verified
Sep 2016
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
626 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast
    Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
  • Placebo Comparator: Placebo
    Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.

Primary Outcome Measure

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Baseline to Week 24 ]

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