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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01509677
First received: December 21, 2011
Last updated: February 18, 2016
Last verified: February 2016

December 21, 2011
February 18, 2016
February 2012
February 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01509677 on ClinicalTrials.gov Archive Site
  • 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 [%]
Same as current
Not Provided
Not Provided
 
Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • COPD
  • Chronic Obstructive Pulmonary Disease
  • Drug: Roflumilast
    500 μg tablet, once daily, oral administration in the morning after breakfast
  • Drug: Placebo
    tablet, once daily, oral administration in the morning after breakfast
  • Active Comparator: Roflumilast
    500 μg tablet, once daily, oral administration in the morning after breakfast
    Intervention: Drug: Roflumilast
  • Active Comparator: Placebo
    tablet, once daily, oral administration in the morning after breakfast
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Poland,   Sweden,   United Kingdom
Italy
 
NCT01509677
RO-2455-402-RD, 2011-000582-13, U1111-1155-8767
No
Not Provided
Not Provided
Takeda
Takeda
Not Provided
Not Provided
Takeda
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP