Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)

• Sponsor: Chiesi SA/NV (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04611633
• Collaborator: (none)
• Enrollment: 14
• Locations: 11
• Actual Duration (Months): 7.9
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Combination Product: Trimbow

Detailed Description

This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Observational Study in COPD Patients Evaluating the Quality of Life in Patients Switching From a Dual Therapy to a Fixed LABA/LAMA/ICS Triple Therapy in Routine Practice
• Actual Study Start Date: Jan 18, 2021
• Actual Primary Completion Date: Sep 16, 2021
• Actual Study Completion Date: Sep 16, 2021

Outcome Measures

Primary Outcome Measures

1. COPD symptoms [6 months]

   The patient's COPD symptoms at month 6 (visit 3), compared to baseline. This is measured by the COPD Assessment Test (CAT) questionnaire.

Secondary Outcome Measures

1. COPD symptoms [3 months]

   The patient's COPD symptoms at month 3 (visit 2)

2. Quality of sleep [6 months]

   The quality of sleep of the patients using the CASIS questionnaire at baseline, month 3 and 6 (visit 2 and 3)

3. Treatment satisfaction [6 months]

   The patient's treatment satisfaction score using PGI-C at month 3 and 6 (visit 2 and 3)

4. Rescue medication [6 months]

   Use of rescue medication at baseline and each follow-up visit (question on the past 7 days)

5. Lung function parameters [6 months]

   Lung function parameters (FEV1, FVC) (if available) at baseline and each follow-up visit

Other Outcome Measures

1. Moderate/severe exacerbations [6 months]

   Number of moderate/severe exacerbations at baseline and at month 6

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has provided written informed consent

• Patient is aged 40 years or older

• Current or ex-smokers with a smoking history ≥ 10 pack years

• Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index <0.7; baseline or older spirometry)

• Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study

• Patient is starting treatment with Trimbow® upon decision by their physician

Exclusion Criteria:

• Patients who are hypersensitive to one of the active substances or excipients

• Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment

• Patients on ICS, LABA or LAMA monotherapy

• Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening

• Patients participating simultaneously to other clinical trials or studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General practitioners in the province of East Flanders	Ghent	East Flanders	Belgium	9000
2	General practitioners in the province of Flemish Brabant	Leuven	Flemish Brabant	Belgium	3000
3	General practitioners in the province of Hainaut	Mons	Hainaut	Belgium	7000
4	General practitioners in the province of Limburg	Hasselt	Limburg	Belgium	3500
5	General practitioners in the province of Luxembourg	Arlon	Luxembourg	Belgium	6700
6	General practitioners in the province of Walloon Brabant	Wavre	Walloon Brabant	Belgium	1300
7	General practitioners in the province of West Flanders	Bruges	West Flanders	Belgium	8000
8	General practitioners in the province of Antwerp	Antwerp		Belgium	2000
9	General practitioners in the province of Liège	Liège		Belgium	4020
10	CHU-UCL-Namur	Namur		Belgium	5000
11	General practitioners in the province of Namur	Namur		Belgium	5000

Sponsors and Collaborators

• Chiesi SA/NV

Investigators

• Principal Investigator: Eric Marchand, MD, PhD, CHU Godinne UCL Namur

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiesi SA/NV
• ClinicalTrials.gov Identifier: NCT04611633
• Other Study ID Numbers: CHIESI_NIS_004
• First Posted: Nov 2, 2020
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Dec 9, 2021