Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Condition: COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      This was a multicenter, double-blind, randomized, parallel group, phase 3 study. Patients
      included had a history of COPD (GOLD stage II-III, in Germany stage II only) with chronic
      productive cough.

      There were 2 parallel treatment arms (placebo and roflumilast 500 μg once daily). A 1 to 1
      randomization scheme was used, that is, patients were allocated to roflumilast 500 μg or
      placebo in equal proportions. Randomization was stratified by concomitant LABA use.

      The total duration of this study was 24 weeks maximum per patient. The study consisted of the
      following periods:

        -  Single-blind placebo run-in period (6 weeks) with visits at Week -6 (visit 0 [V0]), Week
           -2 (V1), and Week 0 (V2, randomization visit), during which all patients received
           placebo.

        -  Double-blind treatment period (16 weeks) during which patients received either
           roflumilast or matching placebo with visits at Week 6 (V4), Week 14 (V5), and Week 16
           (V6).

      An additional visit (V3) within 2 weeks after bronchoscopy/bronchial biopsy was performed
      purely as a safety visit. The exact timing of this safety visit was to be determined by the
      investigator. Safety follow-up. All AEs were followed up to 30 days after the double-blind
      treatment period. An additional safety visit, V7, was scheduled within 2 weeks after the
      second bronchoscopy. The exact timing of the safety visit was to be determined by the
      investigator.

      Patients were required not to take any food or drink overnight for at least 8 hours prior to
      returning to the study center for each visit. Patients were also asked to avoid strenuous
      exercise for 8 hours prior to each study visit and to avoid smoking for 4 hours prior to each
      study visit.

      For visits where patients did not undergo blood collections or biopsies, the fasting
      requirement was only mandated if clinically indicated, per investigator judgment.
    

Intervention name(s): Roflumilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 μg tablet, once daily, oral administration in the morning after breakfast; tablet, once daily, oral administration in the morning after breakfast
Other intervention name(s): Daxas; Placebo to Roflumilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Roflumilast; Chronic Obstructive Pulmonary Disease; COPD