Chronic obstructive pulmonary disease (COPD) MedDRA version: 17.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
FLUIDDA nv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient = 30 years old 2. Written informed consent obtained 3. Patient with Body mass index (BMI) = 20 4. Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study 5. COPD patient with GOLD stages C and D 6. Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation 7. Patient with smoking history of at least 10 pack-years 8. Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1 9. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females 2. Patient with severe immunological diseases and/ or severe acute infectious diseases 3. Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1 4. Patient with diagnosis of cancer (except basal cell carcinoma) 5. Patient with a history of depression associated with suicidal ideation or behaviour 6. Patient with moderate or severe hepatic impairment. 7. Patient with lactose intolerance 8. Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. 9. Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit 10. Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy.;Secondary Objective: The secondary study objective is to obtain data about the health related quality of life, lung function tests and exercise tolerance. ;Primary end point(s): - Airway volume (iVaw) - Airway resistance (iRaw) - Lobe volumes (iVlobes) - Air trapping - Internal Lobar Airflow Distribution - Low Attenuation or Emphysema Score - Blood Vessel Density - Airway Wall Thickness - Aerosol deposition concentrations ;Timepoint(s) of evaluation of this end point: January 2017 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Spirometry: • FEV1 • Peak Expiratory Flow (PEF) • Forced Vital Capacity (FVC) • Maximum Expiratory Flow at 50% of FVC (MEF 50) • Maximum Expiratory Flow at 25% of FVC (MEF 25) - Body plethysmography: • Residual Volume (RV) • TLC • FRC • Airway resistance (Raw) - Diffusion capacity • carbon monoxide transfer factor (TCO) • Alveolar volume (VA) - 6MWT: • Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test - PRO: • Borg CR10 Scale: measure of the present dyspnea and leg fatigue before and after exercise • COPD assessment test (CAT): measure of the impact of COPD on your life • Saint George’s Respiratory Questionnaire (SGRQ): measure health related quality of life and comfort ;Timepoint(s) of evaluation of this end point: January 2017 | — |
Countries
Belgium
Contacts
Public ContactJan De Backer
FLUIDDA nv
Outcome results
None listed