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Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01509677
First received: December 21, 2011
Last updated: May 26, 2014
Last verified: May 2014
  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:


Further study details as provided by Takeda:

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 ]
    1. Forced expiratory volume in the first 1 second (FEV1 [L])
    2. Forced vital capacity (FVC [L])
    3. FEV1/FVC [%]


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Recruiting
Großhansdorf, Germany
Recruiting
Hannover, Germany
Recruiting
Heidelberg, Germany
Recruiting
Mainz, Germany
Completed
Mainz, Germany
Poland
Recruiting
Krakow, Poland
Recruiting
Kraków, Poland
Recruiting
Kraków, Poland, 31-066
Sweden
Recruiting
Lund, Sweden, SE-221 85
Recruiting
Lund, Sweden
United Kingdom
Recruiting
East Yorkshire, United Kingdom, HU16 5JQ
Completed
Leicester, United Kingdom, LE3 9QP
Recruiting
London, United Kingdom, EC1M 6BZ
Recruiting
London, United Kingdom
Active, not recruiting
Manchester, United Kingdom, M23 9QZ
Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
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 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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 Takeda:
Roflumilast
Chronic Obstructive Pulmonary Disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014