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

NCT02451540 | Terminated Phase 2

• 1 other identifier: FLUI-2014-134
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; dynamics hyperinflation; Computed Tomography scan; CT scan; Functional Respiratory Imaging; FRI; Roflumilast; PRO

Outcome Measures

Primary Outcomes (9)

• Changes in Airway volume (iVaw)

  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.

  At baseline and after 3 months of treatment

• Changes in Airway resistance (iRaw)

  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.

  At baseline and after 3 months of treatment

• Changes in Lobe volumes (iVlobes)

  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.

  At baseline and after 3 months of treatment

• Changes in Air trapping

  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.

  At baseline and after 3 months of treatment

• 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 β2-agonist (LABA) therapy will be assessed.

  At baseline and after 3 months of treatment

• Low Attenuation or Emphysema Score

  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.

  At baseline and after 3 months of treatment

• Changes in Blood Vessel Density

  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.

  At baseline and after 3 months of treatment

• Changes in Airway Wall Thickness

  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.

  3 months

• Aerosol deposition concentrations

  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.

  At baseline and after 3 months of treatment

Secondary Outcomes (5)

• Changes in Spirometry

  At baseline and after 3 months of treatment

• Changes in Body plethysmography

  At baseline and after 3 months of treatment

• Changes in Diffusion capacity

  At baseline and after 3 months of treatment

• Changes in 6MWT

  At baseline and after 3 months of treatment

• Changes in Patient Related Outcome (PRO)

  At baseline and after 3 months of treatment

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

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

Radiation: HRCT scan; Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

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.

Radiation: HRCT scan; Drug: Placebo of Roflumilast

Interventions

HRCT scan RADIATION

HRCT scan of thorax, at baseline and after 3 months

Placebo; Roflumilast

Placebo of Roflumilast DRUG

Placebo, once a day in the morning during 3 months

Also known as: Placebo

Placebo

Roflumilast DRUG

Roflumilast, once a day in the morning during 3 months

Also known as: Daxas

Roflumilast

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

University Hospital of Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried De Backer, M.D., M.S.

  University Hospital of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 22, 2015
• Study Start: September 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

BE (1)