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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02451540
• Other study ID #: FLUI-2014-134
• Status: Terminated
• Phase: Phase 2
• First received: May 7, 2015
• Last updated: March 19, 2018
• Start date: September 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: March 2018
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Radiation:
• HRCT scan
HRCT scan of thorax, at baseline and after 3 months

Drug:
• Placebo of Roflumilast
Placebo, once a day in the morning during 3 months
• Roflumilast
Roflumilast, once a day in the morning during 3 months

Locations

Country	Name	City	State
Belgium	University Hospital of Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Airway volume (iVaw)	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Airway resistance (iRaw)	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Lobe volumes (iVlobes)	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Air trapping	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Internal Lobar Airflow Distribution	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Low Attenuation or Emphysema Score	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Blood Vessel Density	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Primary	Changes in Airway Wall Thickness	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	3 months
Primary	Aerosol deposition concentrations	By using Functional Respiratory Imaging the efficacy of Roflumilast in addition to long-acting muscarinic antagonist (LAMA)/ long acting ß2-agonist (LABA) therapy will be assessed.	At baseline and after 3 months of treatment
Secondary	Changes in Spirometry	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)	At baseline and after 3 months of treatment
Secondary	Changes in Body plethysmography	Body plethysmography is a composite outcome measure consisting of the following parameters: Residual Volume (RV); TLC; FRC; Airway resistance (Raw)	At baseline and after 3 months of treatment
Secondary	Changes in Diffusion capacity	Diffusion capacity is a composite outcome measure consisting of the following parameters: carbon monoxide transfer factor (TCO); Alveolar volume (VA)	At baseline and after 3 months of treatment
Secondary	Changes in 6MWT	Exercise capacity: distance walked in 6 minutes (m), oxygen saturation measurement will be performed during the test	At baseline and after 3 months of treatment
Secondary	Changes in Patient Related Outcome (PRO)	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	At baseline and after 3 months of treatment