Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice

NCT02675517 | Completed Results

• 1 other identifier: 1237.42
• Study Type: observational
• Target: 1,737
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).

  Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.

  after approximately 6 weeks

Secondary Outcomes (5)

• Changes in the PF-10 Score From Visit 1 to Visit 2

  baseline and approx. week 6

• General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.

  Baseline (Visit 1) and Week 6 (approx.) (Visit 2)

• Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).

  Week 6 (approx.) (Visit 2)

• Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).

  Week 6 (approx.) (Visit 2)

• Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).

  Week 6 (approx.) (Visit 2)

Study Arms (1)

Spiolto Respimat

COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD)guidelines

Drug: Spiolto Respimat

Interventions

Spiolto Respimat DRUG

Tiotropium bromide + Olodaterol

Spiolto Respimat

Eligibility Criteria

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

Study Population

COPD patients

You may qualify if:

• Written informed consent prior to participation
• Female and male patients = 40 years of age
• Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation

You may not qualify if:

• Patients with contraindications according to Spiolto® Respimat® SmPC
• Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
• Patients continuing LABA- Inhalative Corticosteroides (iCS)treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
• Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
• Pregnancy and lactation
• Patients currently listed for lung transplantation
• Current participation in any clinical trial or any other non-interventional study of a drug or device

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

Related Publications (1)

• Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 28.

  PMID: 32857327 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The impact and the interpretation of this Non Interventional Study (NIS) data are limited due to NIS concept

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

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: January 29, 2016
• First Posted: February 5, 2016
• Study Start: January 13, 2016
• Primary Completion: March 10, 2017
• Study Completion: April 11, 2017
• Last Updated: October 15, 2018
• Results First Posted: October 15, 2018

Record last verified: 2018-03

Locations

DE (1)