OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)

NCT02719639 | Completed Results

• 1 other identifier: 1237.44
• Study Type: observational
• Target: 7,443
• Locations: 8 countries
• Sites: 8

Brief Summary

Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.

  The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.

  Approximately 6 weeks

Secondary Outcomes (5)

• Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)

  Baseline and week 6

• General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).

  Baseline and week 6

• Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)

  Approximately 6 weeks

• Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)

  Approximately 6 weeks

• Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)

  Approximately 6 weeks

Eligibility Criteria

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

Study Population

COPDS patients

You may qualify if:

• Written informed consent prior to participation
• Female and male patients with more or equal to 40 years of age
• Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (COPD) Global Initiative for Chronic Obstructive Lung Disease (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 Corticosteroids (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 (9)

Unknown Facility

Multiple Locations, Austria

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Hungary

Location

Unknown Facility

Multiple Locations, Israel

Location

Unknown Facility

Multiple Locations, Romania

Location

Unknown Facility

Multiple Locations, Russia

Location

Unknown Facility

Multiple Locations, Slovakia

Location

Unknown Facility

Multiple Locations, Slovenia

Location

Unknown Facility

Multiple Locations, Switzerland

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

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 data are limited due to the non-interventional study concept. No objective assessment was performed. It might be considered that patients may get used to limited activity and overrate their baseline activity

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: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 25, 2016
• Study Start: April 1, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: January 9, 2019
• Results First Posted: January 9, 2019

Record last verified: 2019-01

Locations

HU (1); RU (1); AU (1); SL (1); RO (1); CH (1); CZ (1); IL (1)