NCT00242320

Brief Summary

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
551

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2005

Geographic Reach
5 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1.7 years

First QC Date

October 19, 2005

Last Update Submit

December 1, 2016

Conditions

COPD

Keywords

COPDchronic obstructive pulmonary diseaseRoflumilast

Outcome Measures

Primary Outcomes (1)

  • mean change from randomization to endpoint in lung function (post bronchodilator)

    12 weeks

Secondary Outcomes (5)

  • mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters

    12 weeks

  • exacerbation rate

    12 weeks

  • adverse events

    12 weeks

  • changes in laboratory values

    12 weeks

  • changes in vital signs

    12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Roflumilast 500 µg

Drug: Roflumilast

2

PLACEBO COMPARATOR

Placebo

Drug: RoflumilastDrug: Placebo

Interventions

RoflumilastDRUG

to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo

12
PlaceboDRUG
2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
  • FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
  • FEV1 (post bronchodilator) 30-80% of predicted
  • Fixed airway obstruction
  • Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
  • Clinically stable COPD within 4 weeks prior to baseline visit
  • Availability of a chest x-ray

You may not qualify if:

  • COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
  • Lower respiratory tract infection
  • Diagnosis of asthma
  • Known alpha-1-antitrypsin deficiency
  • Need for long term oxygen therapy defined as longer or equal 16 hours/day
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
  • Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
  • Diagnosis or history of cancer
  • Clinically significant cardiopulmonary abnormalities
  • Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
  • Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal \> 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
  • Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
  • Alcohol or drug abuse
  • Inability to follow the study procedures due to e.g., language problems, physiological disorders
  • Use of not allowed drugs
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Altana Pharma/Nycomed

Hong Kong, 852, Hong Kong

Location

Altana Pharma/Nycomed

Shatin, NT, Hong Kong, Hong Kong

Location

Altana Pharma/Nycomed

Jalan Rasah, Seremban, 70300, Malaysia

Location

Altana Pharma/Nycomed

Kota Bharu / Kelantan, 16150, Malaysia

Location

Altana Pharma/Nycomed

Kota Kinabalu, Sabah, 88586, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 50590, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 56000, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 59100, Malaysia

Location

Altana Pharma/Nycomed

Manila, 1000, Philippines

Location

Altana Pharma/Nycomed

Quezon City, 1100, Philippines

Location

Altana Pharma/Nycomed

Quezon City, 1102, Philippines

Location

Altana Pharma/Nycomed

Quezon City, 850, Philippines

Location

Altana Pharma/Nycomed

Quezon City, 870, Philippines

Location

Altana Pharma/Nycomed

Anvang-Si, Gveonggi-Do, 431-070, South Korea

Location

Altana Pharma/Nycomed

Gangwon-do, 220-701, South Korea

Location

Altana Pharma/Nycomed

Gangwon-Do, 220-711, South Korea

Location

Altana Pharma/Nycomed

Gwangju, 501-757, South Korea

Location

Altana Pharma/Nycomed

Gyeonggi-do, 420-767, South Korea

Location

Altana Pharma/Nycomed

Jiniu-Si. Gveongsangnam-Do, 660-702, South Korea

Location

Altana Pharma/Nycomed

Jungbuk, 361-711, South Korea

Location

Altana Pharma/Nycomed

Seoul, 135-720, South Korea

Location

Altana Pharma/Nycomed

Seoul, 136-705, South Korea

Location

Altana Pharma/Nycomed

Seoul, 137-701, South Korea

Location

Altana Pharma/Nycomed

Seoul, 138-736, South Korea

Location

Altana Pharma/Nycomed

Seoul, 140-757, South Korea

Location

Altana Pharma/Nycomed

Seoul, 158-710, South Korea

Location

Altana Pharma/Nycomed

Uijongbu-city, Gveonggi-Do, 480-130, South Korea

Location

Altana Pharma/Nycomed

Ulsan, 682-060, South Korea

Location

Altana Pharma/Nycomed

Kaohsiung City, 886-807, Taiwan

Location

Altana Pharma/Nycomed

Taipei, 886-114, Taiwan

Location

Altana Pharma/Nycomed

Taipei, Taiwan

Location

Altana Pharma/Nycomed

Tau-Yuan, 886-333, Taiwan

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2007

Study Completion

August 1, 2007

Last Updated

December 2, 2016

Record last verified: 2016-09

Locations

HK(2)MY(6)PH(5)TW(4)KR(15)