Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD

Sponsor
AstraZeneca
Study ID
NCT02165826
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast tablets
  • Roflumilast Placebo — DRUG
    Roflumilast placebo-matching tablets
  • Standard of Care COPD Treatment — DRUG
    The participant is on standard of care COPD maintenance treatment including LABAs, long-acting anticholinergics, or any combination thereof taken on a constant daily dose within 12 weeks prior to Screening (Visit V0) Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics: Tiotropium, Aclidinium.

Study Details

The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week main period, and to evaluate if participants who do not tolerate roflumilast 500 μg OD have a drug exposure with 250 μg roflumilast OD similar to that observed in other participants with the 500 μg OD dose.

Key Dates

Start date
May 1, 2014
Status verified
Mar 2017
Primary completion
Sep 1, 2015
Completion
Sep 1, 2015

Study Design

Enrollment
1,323 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roflumilast 250 μg once daily
    Roflumilast 250 μg, tablets, orally, once daily for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks.
  • Experimental: Roflumilast 500 μg once daily
    Roflumilast 500 μg tablets, orally, once daily for 12 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks.
  • Experimental: Roflumilast 500 μg every other day
    Roflumilast 500 μg, tablets, orally, every other day, and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks. Any participants not tolerating study treatment will be prematurely discontinued and will receive roflumilast 250 μg, tablets, orally, once daily for 8 weeks.

Primary Outcome Measure

Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason [ Time Frame: Baseline to Week 12 (Main Period) ]

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