Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01580748

Enrollment

Registered

2012-04-19

Start date

2012-05-31

Completion date

2013-01-31

Last updated

2012-04-19

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

Conditions

Symptomatic Bronchiectasis

Brief summary

There is currently no effective treatment of bronchiectasis other than treating its complications such as infection, bleeding, etc. Roflumilast is a newly developed anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that Roflumilast might be effective in symptomatic bronchiectasis patients

Interventions

DRUGRoflumilast

500 microgram once daily for 16 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Bronchiectasis on CT * chronic (\>3 months) cough or sputum

Exclusion criteria

* needs hospitalization * life expectancy of less than six months * pregnancy or breast feeding * history of acute respiratory infection within 4 weeks * history of taking antibiotics within 4 weeks * active hemoptysis * %predicted FEV \< 30% * severe liver disease (Child Pugh Class B or C)

Design outcomes

Primary

Measure	Time frame
change of CASA-Q score	16 weeks

Secondary

Measure	Time frame
change of FEV1	16 weeks
change of FVC	16 weeks
alanine transaminase	4 weeks

Countries

South Korea

Contacts

Primary ContactChoon-Taek Lee, M.D., Ph.D.

ctlee@snubh.org+82-31-787-7002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026