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Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]

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ClinicalTrials.gov Identifier: NCT03265145
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Healthcore
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment

The secondary objectives of this study include:

  1. To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy.
  2. To compare the time to first severe COPD exacerbation in both treatment arms.
  3. To compare the annual rate of severe COPD exacerbations in both treatment arms.
  4. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Stiolto Respimat Drug: ICS (Inhaled Corticosteroid) (Triple therapy) Drug: LABA (Long-Acting Beta Agonist) (Triple therapy) Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Stiolto Respimat Drug: Stiolto Respimat
Duration - 12 months
Other Name: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

Active Comparator: ICS plus LABA plus LAMA (triple therapy)
ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)
Drug: ICS (Inhaled Corticosteroid) (Triple therapy)
Duration - 12 months

Drug: LABA (Long-Acting Beta Agonist) (Triple therapy)
Duration - 12 months

Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Duration - 12 months




Primary Outcome Measures :
  1. Time to first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Annual rate of moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  2. Time to first severe chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 12 months ]
  3. Annual rate of severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]
  4. Proportion of patients with moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations [ Time Frame: 12 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD diagnosis as defined by the study physician
  • Currently on one of the following maintenance therapies:

    • LAMA monotherapy
    • LABA monotherapy
    • ICS/LABA (FDC)
  • Physician determination that patient is not controlled on current pharmacotherapy
  • Adult patient 40 years of age or older at time of study enrollment
  • Willingness and ability to understand and provide documented Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to commencement of any study required assessments, either directly or through Legally Authorized Representative.

Exclusion Criteria:

  • Currently on LAMA/LABA (free or FDC) or triple therapy (ICS plus LABA plus LAMA)
  • Contraindication to any study medications (LAMA, LABA or ICS)
  • Documented diagnosis of current asthma
  • Pregnant or nursing women
  • Women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.

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 ClinicalTrials.gov identifier (NCT number): NCT03265145


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

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Sponsors and Collaborators
Boehringer Ingelheim
Healthcore

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03265145     History of Changes
Other Study ID Numbers: 1237-0064
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Muscarinic Antagonists
Tiotropium Bromide
Olodaterol
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents