The trial investigates the effect of 500 µg roflumiliast tablets once daily on acute worsening of symptoms (exacerbations) treated with standard therapy in patiens with chronic obstructive pulmonary disease (COPD)

Effect of roflumilast 500 µg tablets once daily at acute COPD exacerbations treated with standard therapy of oral steroids and antibiotics. A randomised, double-blind, placebo-controlled, parallel-group trial. - TREAT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002905-31-GB

Enrollment

140

Registered

2011-10-19

Start date

2011-12-01

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Acute exacerbations of chronic obstructive pulmonary disease (COPD) MedDRA version: 16.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 MedDRA version: 16.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855

Interventions

Trade Name: Daxas Product Name: Roflumilast 500µg film-coated tablet Product Code: BY217 Pharmaceutical Form: Film-coated tablet INN or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: I1. Written informed consent (IC); I2. Age =40 years; I3. History of COPD for at least 12 months prior to enrolment (Visit V0); I4. Chronic productive cough for 3 months in each of the 2 years prior to enrolment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrolment; I5. Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour; I6. Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: E1. Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis] or active tuberculosis); E2. Known a-1-antitrypsin deficiency; E3. Recurrent exacerbations (within 8 weeks of a preceding exacerbation); E4. Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrolment; E5. Treatment with PDE4 inhibitors within 3 months prior to Visit V0; Criteria within ethical considerations in terms of general health: E6. Oxygen therapy (more than 8 hours daily); E7. Formal contraindications to sputum collection or impossibility to obtain a sample of sputum valid for analysis; E8. Respiratory failure when presenting at Visit V0; E9. Severe psychiatric or neurological disorders; E10. History of depression associated with suicidal ideation or behaviour; E11. Congestive heart failure severity grade IV according to the New York Heart Association Functional Classification; E12. Haemodynamically significant cardiac arrhythmias or heart valve deformations; E13. Immunological diseases or known infection with human immunodeficiency virus; E14. Liver impairment Child-Pugh B and C and/or active viral hepatitis; E15. Severe acute infectious diseases; E16. Any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) within 5 years before trial start; E17. Alcohol or drug abuse within the past year; E18. Suspected hypersensitivity to the IMP or ingredients thereof, or any other contraindication for the use thereof; E19. Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilised/hysterectomised or post-menopausal >1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases; E20. Pregnancy, breast feeding, planned oocyte donation or oocyte implantation; E21. Planned donation of germ cells, blood, organs or bone marrow during the course of the trial; E22. Participation in another trial (use of investigational product) within 30 days of Visit V0 or re-entry of patients previously enroled in this trial; E23. Suspected inability or unwillingness to comply with trial procedures (e.g. language problems, psychological disorders); E24. Suffering from any concomitant disease that might interfere with trial procedures or evaluations; E25. Use of disallowed drugs (see Section 6.8); E26. Employee at the trial site, relative or spouse of the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To investigate the effect of roflumilast 500 µg tablets once daily (od) versus placebo on sputum neutrophilic inflammation at acute exacerbations of chronic obstructive pulmonary disease (COPD). ; Secondary Objective: • To investigate the effect of roflumilast on other secondary sputum and blood biomarkers, and on lung function. • To investigate the effect of roflumilast on length, severity and recovery periods of acute COPD exacerbations (based on diary reports), and on other daily diary outcomes with respect to the exacerbation. • To investigate the effect of roflumilast on patient-reported outcomes with respect to the exacerbation. • To provide data on safety and tolerability of roflumilast intake during exacerbation episodes and following weeks. ;Primary end point(s): The primary endpoint is change in sputum neutrophil counts from V0 to V2 (Day 14). Missing values will be imputed by the last available measurement after V0 up to V2.;Timepoint(s) of evaluation of this end point: V0 (Day 1), V1 (Day 7), V2 (Day 14).	—

Measure

Time frame

Main Objective: • To investigate the effect of roflumilast 500 µg tablets once daily (od) versus placebo on sputum neutrophilic inflammation at acute exacerbations of chronic obstructive pulmonary disease (COPD). ; Secondary Objective: • To investigate the effect of roflumilast on other secondary sputum and blood biomarkers, and on lung function. • To investigate the effect of roflumilast on length, severity and recovery periods of acute COPD exacerbations (based on diary reports), and on other daily diary outcomes with respect to the exacerbation. • To investigate the effect of roflumilast on patient-reported outcomes with respect to the exacerbation. • To provide data on safety and tolerability of roflumilast intake during exacerbation episodes and following weeks. ;Primary end point(s): The primary endpoint is change in sputum neutrophil counts from V0 to V2 (Day 14). Missing values will be imputed by the last available measurement after V0 up to V2.;Timepoint(s) of evaluation of this end point: V0 (Day 1), V1 (Day 7), V2 (Day 14).

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Secondary

Measure	Time frame
Secondary end point(s): 1) Proportion of patients whose sputum neutrophil counts have returned to stable state levels at Day 14 2) Induced sputum markers, serum biomarkers and lung function 3) Continuous endpoints and scores, which are derived from patient reported outcomes (CAT, EXACT-PRO) and diaries (PEF, symptom score, hours out of house) 4) Diary endpoints exacerbation length, time to next exacerbation and length of stay in hospital 5) Hospitalisation rate ; Timepoint(s) of evaluation of this end point: 1) Will be compared between treatments with a continuity corrected Chi-squared test. For stable state levels, the value from a visit where the patient is free of exacerbations will be used; specifications will be provided in the SAP. 2) Will be analysed by repeated measures with change from Visit V0 (to Visit V1, to Visit V2, to Visit V3) as the dependent variable. A second model will include the changes from V0 to the last available measurement up to VFU. 3) /4) /5) Will be presented descriptively (including graphical displays) on a day by day basis and additionally on a weekly basis, stratified by treatment. The time period covered by the displays will be Day -14 up to Day 56 (VFU).	—

Measure

Time frame

Secondary end point(s): 1) Proportion of patients whose sputum neutrophil counts have returned to stable state levels at Day 14 2) Induced sputum markers, serum biomarkers and lung function 3) Continuous endpoints and scores, which are derived from patient reported outcomes (CAT, EXACT-PRO) and diaries (PEF, symptom score, hours out of house) 4) Diary endpoints exacerbation length, time to next exacerbation and length of stay in hospital 5) Hospitalisation rate ; Timepoint(s) of evaluation of this end point: 1) Will be compared between treatments with a continuity corrected Chi-squared test. For stable state levels, the value from a visit where the patient is free of exacerbations will be used; specifications will be provided in the SAP. 2) Will be analysed by repeated measures with change from Visit V0 (to Visit V1, to Visit V2, to Visit V3) as the dependent variable. A second model will include the changes from V0 to the last available measurement up to VFU. 3) /4) /5) Will be presented descriptively (including graphical displays) on a day by day basis and additionally on a weekly basis, stratified by treatment. The time period covered by the displays will be Day -14 up to Day 56 (VFU).

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Countries

United Kingdom

Contacts

Public ContactClinical Trial Management Daxas

Nycomed GmbH

hildegard.boss@nycomed.com+49-(0)7531-84-2370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026