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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02720757
Recruitment Status : Terminated (Recruitment failure)
First Posted : March 28, 2016
Last Update Posted : November 9, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Spiolto Respimat

Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : December 14, 2017
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
Tiotropium bromide + Olodaterol

Primary Outcome Measures :
  1. Changes in physical functioning based on Patient questionnaire (PF-10) scores [ Time Frame: 4-6 weeks ]

Secondary Outcome Measures :
  1. Patients' satisfaction with Spiolto Respimat using a Patient Satisfaction Survey [ Time Frame: 4-6 weeks ]
  2. Patients' general condition using the Physician's Global Evaluation (PGE) scale [ Time Frame: 4-6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic Obstructive Pulmonary Disease (COPD) patients

Inclusion criteria:

  1. Written informed consent prior to participation
  2. Female and male patients = 40 years of age
  3. 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

Exclusion criteria:

  1. Patients with contraindications according to Spiolto® Respimat® SmPC
  2. 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.
  3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroides (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
  4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
  5. Pregnancy and lactation
  6. Patients currently listed for lung transplantation
  7. Current participation in any clinical trial or any other non-interventional study of a drug or device Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02720757

Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Multiple Locations, Belgium
Multiple Locations, Denmark
Multiple Locations, Luxembourg
Multiple Locations, Netherlands
One Or Multiple Investigational Sites, Portugal
One Or Multiple Investigational Site, Sweden
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT02720757     History of Changes
Other Study ID Numbers: 1237.45
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action