Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified May 2012 by Nycomed: A Takeda Company
Sponsor:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT01509677
First received: December 21, 2011
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained.
Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD Chronic Obstructive Pulmonary Disease |
Drug: Roflumilast Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A 16-week, Randomized, Placebo-controlled, Double Blind, and Parallel Group Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Roflumilast
U.S. FDA Resources
Further study details as provided by Nycomed: A Takeda Company:
Primary Outcome Measures:
- The primary endpoint will be the number of inflammatory cells CD8+ in bronchial biopsy tissue specimen (sub-mucosa) measured at randomization visit V2 and at the end of the intervention period (V6). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Additional cell count in biopsied material (sub-mucosa and epithelium) [cells/mm2] [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Total and differential cell counts in induced sputum [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Concentration of inflammatory biomarkers in sputum [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Explorative examination of inflammatory parameter in sputum using the 46-biomarker Multi-Analyte Profiling (MAP) technology (Human InflammationMAP® v.1, Rules-Based Medicine, Inc., Austin, TX, U.S.A.)
- Concentration of inflammatory biomarkers in blood serum [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Explorative examination of inflammatory parameter in blood serum using the 46-biomarker Multi-Analyte Profiling (MAP) technology (Human InflammationMAP® v.1, Rules-Based Medicine, Inc., Austin, TX, U.S.A.)
- Pulmonary function changes in the course of the trial [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Forced expiratory volume in the first 1 second (FEV1 [L])
- Forced vital capacity (FVC [L])
- FEV1/FVC [%]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Roflumilast |
Drug: Roflumilast
500 μg tablet, once daily, oral administration in the morning after breakfast
|
| Active Comparator: Placebo |
Drug: Placebo
tablet, once daily, oral administration in the morning after breakfast
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Major Inclusion Criteria:
- Giving written informed consent
- History of COPD (according to GOLD 2009) for at least 12 months prior to baseline visit V0 associated with chronic productive cough for at least three months in each of the two years prior to baseline visit V0 (with other causes of productive cough excluded)
- Outpatients 40-80 years of age
- Post-bronchodilator 30% ≤FEV1 ≤80% predicted
- Post-bronchodilator FEV1/FVC ratio ≤70%
- Current or former smokers with smoking history ≥20 pack years
Main Exclusion Criteria:
• Criteria affecting the read-out parameters of the trial:
- Clinical instability, defined as experiencing a COPD exacerbation six months prior to V0
- An upper/lower respiratory tract infection which has not resolved four weeks prior to V0
- Diagnosis of asthma and/or other relevant lung disease
- Known alpha-1-antitrypsin deficiency
- Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological mechanism
- Other protocol-defined exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509677
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Germany | |
| Nycomed Investigational Site | Not yet recruiting |
| Großhansdorf, Germany, 22927 | |
| Nycomed Investigational Site | Not yet recruiting |
| Hannover, Germany, 30625 | |
| Nycomed Investigational Site | Not yet recruiting |
| Mainz, Germany, 55131 | |
| Italy | |
| Nycomed Investigational Site | Not yet recruiting |
| Parma, Italy, 43100 | |
| Poland | |
| Nycomed Investigational Site | Not yet recruiting |
| Kraków, Poland, 31-501 | |
| Nycomed Investigational Site | Not yet recruiting |
| Kraków, Poland, 31-066 | |
| Sweden | |
| Nycomed Investigational Site | Recruiting |
| Lund, Sweden, Se-221 85 | |
| United Kingdom | |
| Nycomed Investigational Site | Not yet recruiting |
| East Yorkshire, United Kingdom, HU16 5JQ | |
| Nycomed Investigational Site | Not yet recruiting |
| Leicester, United Kingdom, LE3 9QP | |
| Nycomed Investigational Site | Not yet recruiting |
| London, United Kingdom, E2 9JX | |
| Nycomed Investigational Site | Not yet recruiting |
| Manchester, United Kingdom, M23 9QZ | |
Sponsors and Collaborators
Nycomed: A Takeda Company
More Information
No publications provided
| Responsible Party: | Nycomed: A Takeda Company |
| ClinicalTrials.gov Identifier: | NCT01509677 History of Changes |
| Other Study ID Numbers: | RO-2455-402-RD, 2011-000582-13 |
| Study First Received: | December 21, 2011 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Nycomed: A Takeda Company:
|
Roflumilast Chronic Obstructive Pulmonary Disease COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive |
Respiratory Tract Diseases Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013