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Fixed Dose Triple Therapy in Severe Chronic Obstructive Pulmonary Disease in a Real World Setting (TRIVOLVE)

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ClinicalTrials.gov Identifier: NCT03627858
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi SA/NV

Brief Summary:
The rationale for this non-interventional study in confirmed moderate to severe chronic obstructive pulmonary disease patients aged 40 years and above, is to assess real-life effectiveness and safety of Trimbow® in clinical practice, and to bridge the gap with the existing clinical data.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Drug: beclomethasone / formoterol / glycopyrronium

Detailed Description:

This non-interventional study assesses the real-life effectiveness and safety of the fixed triple therapy Trimbow® compared to free triple therapy, considering patient individual data, in clinical practice at second and thirdline centres in patients with confirmed moderate to severe chronic obstructive pulmonary disease.

This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Formoterol


Intervention Details:
  • Drug: beclomethasone / formoterol / glycopyrronium
    As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.
    Other Name: Trimbow®


Primary Outcome Measures :
  1. Inhalation technique score [ Time Frame: up to 6 months ]

    Change in Inhalation Technique Score, measured as percentage of correct steps on the Inhalation Checklist (itemized instructions of inhaler correct use per respective Summaries of Product Characteristics) at each routine follow-up visit up to 6 months versus baseline.

    This is an hypothesis generating study. No formal primary endpoint is defined; parameters are evaluated in an exploratory or descriptive manner.



Secondary Outcome Measures :
  1. Treatment adherence score [ Time Frame: up to 6 months ]
    Degree of treatment adherence measured via the mean score on the Test of Adherence to Inhalers (TAI) questionnaire, including 5 questions completed by the patient (each item scored from 1 (worst) to 5 (best) with a range from 10 to 50) and 2 items completed by the physician (each item scored 1 (bad) or 2 (good) with a range from 2 to 4) at baseline and each routine follow-up visit up to 6 months versus baseline.

  2. Number of inhaled doses recorded by dose counter since previous visit [ Time Frame: up to 6 months ]
    Number of inhaled doses recorded by dose counter of the inhaler since previous visit, at the first and second routine follow-up visit.

  3. Patient's treatment satisfaction score using visual analogue scale (0-10) [ Time Frame: up to 6 months ]
    The patient's treatment satisfaction score measured on a visual analogue scale from 0 (worst) to 10 (best), at baseline and each routine follow-up visit.

  4. Number of rescue medication used within 7 days prior to each visit [ Time Frame: up to 6 months ]
    The number of rescue medication used within 7 days prior to each visit, recorded at baseline and each routine follow-up visit.

  5. Patient's lung function as measured by spirometry [ Time Frame: up to 6 months ]
    The pre and post bronchodilator forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) are measured at baseline and each routine follow-up visit.

  6. Symptoms score by the Chronic obstructive pulmonary disease Assessment Test (CAT) questionnaire [ Time Frame: up to 6 months ]
    Patients complete the 8-item CAT questionnaire at baseline and each follow-up visit. Total scores range from 0 to 40 and higher scores indicate a worse health status.


Other Outcome Measures:
  1. Number of moderate and severe exacerbations at baseline (12 months prior to start) and last follow-up visit [ Time Frame: up to 6 months ]
    The number of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit. Moderate exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment. Severe exacerbations are defined as exacerbations that require oral corticosteroid and/or antibiotic treatment plus hospital admission.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients aged 40 years or above diagnosed with chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) who were prescribed Trimbow®
Criteria

Inclusion Criteria:

  • Patient has provided written informed consent
  • Patient is aged 40 years or older at time of initiation of Trimbow® treatment
  • Patient is diagnosed with moderate or severe chronic obstructive pulmonary disease confirmed by spirometry (post-bronchodilation) based on the Global Initiative for chronic obstructive lung disease (GOLD) 2018 classification
  • Patient treated with double inhalation or free triple therapy (using at least 2 devices) who are prescribed Trimbow®

Exclusion Criteria:

• Hypersensitivity to the active substances or to any of the excipients listed below:

  • Ethanol anhydrous
  • Hydrochloric acid
  • Norflurane (propellant)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627858


Contacts
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Contact: Sofie Geelissen, PhD +3227884222 s.geelissen@chiesi.com
Contact: Ina Gesquiere, PharmD,PhD i.gesquiere@chiesi.com

Locations
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Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Contact: Lieven Bedert, MD       lieven.bedert@zna.be   
Universitair Ziekenhuis Antwerpen Not yet recruiting
Antwerp, Belgium, 2650
Contact: Veronique Verplancke, MD         
GZA Campus Sint-Vincentius Recruiting
Antwerp, Belgium
Contact: Inge Hantson         
Hôpital Erasme Recruiting
Brussels, Belgium
Contact: Dimitri Leduc         
UZ Brussel Recruiting
Brussel, Belgium
Contact: Daniel Schuermans         
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Pierre Fievez, MD         
Clinique Notre-Dame de Grâce ASBL Gosselies Recruiting
Charleroi, Belgium
Contact: Véronique Goblet         
UZ Gent Recruiting
Gent, Belgium
Contact: Stefanie Vermeersch         
AZ Groeninge Recruiting
Kortrijk, Belgium
Contact: Fem De Plus         
CHR de la Citadelle Recruiting
Liège, Belgium
Contact: Geoffroy De Fooz         
AZ Sint-Maarten Recruiting
Mechelen, Belgium
Contact: Muriel Lins         
Hôpital André Vésale Recruiting
Montigny-le-Tilleul, Belgium
Contact: Rudi Peché, MD         
Clinique Saint-Luc Bouge Recruiting
Namur, Belgium
Contact: Richard Frognier         
AZ Delta Recruiting
Roeselare, Belgium
Contact: Lore Carton         
Hospital Center De Wallonie Picarde Recruiting
Tournai, Belgium
Contact: Alain Palem, MD         
Sponsors and Collaborators
Chiesi SA/NV
Investigators
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Principal Investigator: Guy Brusselle, MD-PhD University Ghent

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Responsible Party: Chiesi SA/NV
ClinicalTrials.gov Identifier: NCT03627858     History of Changes
Other Study ID Numbers: CHIESI_NIS_0001
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Beclomethasone
Muscarinic Antagonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Cholinergic Antagonists
Cholinergic Agents