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]

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Stiolto Respimat; Drug: LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy); Drug: ICS (Inhaled Corticosteroid) (Triple therapy); Drug: LABA (Long-Acting Beta Agonist) (Triple therapy)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03265145

1237-0064

Details and patient eligibility

About

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.

Enrollment: 714 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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714 participants in 2 patient groups

Stiolto Respimat

Experimental group

Treatment:

Drug: Stiolto Respimat

ICS plus LABA plus LAMA (triple therapy)

Active Comparator group

Description:

ICS (Inhaled Corticosteroid) plus LABA (Long-Acting Beta Agonist) plus (Long-Acting Muscarinic Antagonist)

Treatment:

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

Drug: ICS (Inhaled Corticosteroid) (Triple therapy)

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