Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

NCT02720757 | Terminated Results

• 1 other identifier: 1237.45
• Study Type: observational
• Target: 132
• Locations: 6 countries
• Sites: 6

Brief Summary

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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 After Approximately (Approx.) 6 Weeks After Baseline

  "Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "No, not limited at all"). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented

  Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

Secondary Outcomes (5)

• Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)

  Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

• General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)

  Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

• Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction

  Visit 2 (approx. 6 weeks post baseline)

• Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device

  Visit 2 (approx. 6 weeks post baseline)

• Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device

  Visit 2 (approx. 6 weeks post baseline)

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

Chronic Obstructive Pulmonary Disease (COPD) patients

You may qualify if:

• Written informed consent prior to participation
• Female and male patients = 40 years of age
• Patients diagnosed with Chronic Obstructive Pulmonary Disease (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 Long-acting beta2 adrenoceptor agonist\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.
• Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

Unknown Facility

Multiple Locations, Belgium

Location

Unknown Facility

Multiple Locations, Denmark

Location

Unknown Facility

Multiple Locations, Luxembourg

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

One Or Multiple Investigational Sites, Portugal

Location

Unknown Facility

One Or Multiple Investigational Site, Sweden

Location

Related Publications (1)

• Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28.

  PMID: 34394782 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 (NIS) data are limited due to the non-interventional study 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: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 28, 2016
• Study Start: August 26, 2016
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-04

Locations

LU (1); PT (1); DK (1); NL (1); SE (1); BE (1)