Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug

NCT05362487 | Terminated Results FDA Drug FDA Device

• 1 other identifier: 0205-0549
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)

  Number of participants with 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 in patients with high CCQ baseline score (≥ 2) is reported. The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ \< 1); acceptable for moderate disease (1 ≤CCQ \<2); instable-severe limited (2 ≤ CCQ \< 3); very instable-very severe limited (CCQ ≥ 3).

  Baseline and at Week 8.

Secondary Outcomes (5)

• Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score

  Baseline and at Week 8.

• Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in All Patients Independently From CCQ Baseline Score

  Baseline and at Week 8.

• Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in Patients With High CCQ Baseline Score (≥ 2)

  Baseline and at Week 8.

• Breathlessness of the Patients at Baseline and at Week 8

  At baseline and at Week 8.

• Changes in Breathlessness of the Patients From Baseline to Week 8

  At baseline and at Week 8.

Study Arms (1)

Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®

Device: Spiriva® Respimat®; Device: Spiriva® HandiHaler®; Drug: Tiotropium bromide

Interventions

Spiriva® Respimat® DEVICE

Spiriva® Respimat®

Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®

Spiriva® HandiHaler® DEVICE

Spiriva® HandiHaler®

Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®

Tiotropium bromide DRUG

Tiotropium bromide

Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Obstructive Pulmonary Disease (COPD) planned to be switched according to the respective Summary of product characteristics (SmPC) and consenting to participate in the study are eligible. To avoid any selection bias, all eligible patients will be invited to participate in this study, in the order in which their eligibility is determined.

You may qualify if:

• Participants ≥ 40 years of age at baseline visit
• Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
• Signed written informed consent form to participation

You may not qualify if:

• Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
• Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
• Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
• Patients with confirmed diagnosis of only asthma
• Patients who are pregnant or breastfeeding
• Patients participating in an ongoing interventional study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal

Liestal, 4410, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: August 5, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: February 26, 2025
• Results First Posted: July 8, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)