Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

Phase 2

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Radiation: HRCT scan; Drug: Roflumilast; Drug: Placebo of Roflumilast

• Registration Number: NCT02451540
• Lead Sponsor: FLUIDDA nv

Brief Summary

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-22
• Study Start: 2015-09
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Male or female patient ≥ 30 years old
• Written informed consent obtained
• Patient with Body mass index (BMI) ≥ 20
• 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
• COPD patient with GOLD stages C and D
• Patient with a Borg Fatigue score after the 6MWT on screening above 4 to indicate the susceptibility to dynamics hyperinflation
• Patient with smoking history of at least 10 pack-years
• Patient takes a combination therapy of LABA/ LAMA at least 6 weeks before visit 1
• Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

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Exclusion Criteria

• Pregnant or lactating females
• Patient with severe immunological diseases and/ or severe acute infectious diseases
• Patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1
• Patient with diagnosis of cancer (except basal cell carcinoma)
• Patient with a history of depression associated with suicidal ideation or behaviour
• Patient with moderate or severe hepatic impairment.
• Patient with lactose intolerance
• Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
• Patient who received inhalation corticosteroids (ICS) within the last 6 weeks prior to the screening visit
• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roflumilast	HRCT scan	Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment
Roflumilast	Roflumilast	Patient will take Roflumilast (500 micrograms) once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months of treatment
Placebo	HRCT scan	Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.
Placebo	Placebo of Roflumilast	Patient will take the Placebo of Roflumilast once a day for 3 months. A HRCT scan will be taken at baseline and after 3 months.

Primary Outcome Measures

Name	Time	Method
Changes in Air trapping	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Blood Vessel Density	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Airway Wall Thickness	3 months	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Airway volume (iVaw)	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Airway resistance (iRaw)	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Lobe volumes (iVlobes)	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Changes in Internal Lobar Airflow Distribution	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Low Attenuation or Emphysema Score	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.
Aerosol deposition concentrations	At baseline and after 3 months of treatment	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting β2-agonist (LABA) therapy will be assessed.

Secondary Outcome Measures

Name	Time	Method
Changes in 6MWT	At baseline and after 3 months of treatment	Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test
Changes in Patient Related Outcome (PRO)	At baseline and after 3 months of treatment	Patient Related Outcome is a composite outcome measure consisting of the following questionnaires: * 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
Changes in Spirometry	At baseline and after 3 months of treatment	Spirometry is a composite outcome measure consisting of the following parameters: * 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)
Changes in Body plethysmography	At baseline and after 3 months of treatment	Body plethysmography is a composite outcome measure consisting of the following parameters: * Residual Volume (RV); * TLC; * FRC; * Airway resistance (Raw)
Changes in Diffusion capacity	At baseline and after 3 months of treatment	Diffusion capacity is a composite outcome measure consisting of the following parameters: * carbon monoxide transfer factor (TCO); * Alveolar volume (VA)

Trial Locations

Locations (1)

University Hospital of Antwerp; 🇧🇪 Edegem, Antwerp, Belgium