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A confirmatory study of APTA-2217 in adult patients with bronchial asthma (A placebo-controlled double-blind comparative study)

A confirmatory study of APTA-2217 in adult patients with bronchial asthma (A placebo-controlled double-blind comparative study)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220094
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

Bronchial asthma

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] Patient with bronchial asthma who are 20 to 70 years old, non-smoker or ex-smoker for 12 months or more, 60 to 80 % of predicted FEV1 [Exclusion criteria] Patients with poorly controlled asthma, patients with a clear diagnosis of seasonal asthma and patients who have concurrent respiratory diseases such as COPD, chronic bronchitis, pulmonary emphysema, and bronchiectasis, which are judged to have an effect on 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