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A confirmatory study of APTA-2217 in patients with chronic obstructive pulmonary disease (A placebo-controlled double-blind, parallel group study)

A confirmatory study of APTA-2217 in patients with chronic obstructive pulmonary disease (A placebo-controlled double-blind, parallel group study)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220095
Enrollment
Unknown
Registered
2005-09-12
Start date
2005-09-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

investigational material(s) Generic name etc : APTA-2217 (roflumilast) INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administr

Sponsors

Tanabe Pharma Corporation was the original trial sponsor; however Astra Zeneca is now the Responsible Party
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Inclusion criteria] Patients with chronic obstructive pulmonary disease who are 40 years old or more, current smoker or ex-smoker, 30 to 80 % of predicted FEV1 after inhalation of short acting beta stimulant. [Exclusion criteria] Patients with poorly controlled COPD, patients who need for long-term oxygen therapy, patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myaoma), which are considered to affect the evaluation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy (pulmonary function test), safety and pharmacokinetics—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026