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Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Tennessee Graduate School of Medicine

About this trial

The purpose of this study is to compare the effectiveness of inhaled bronchodilators delivered via nebulizers vs. dry powder inhalers (DPIs) in symptomatic participants with Chronic Obstructive Pulmonary Disease (COPD) who have airflow obstruction (FEV1/FVC ≤ 70%) and show significant air trapping (RV ≥ 120% of predicted).

The investigators hypothesize that, in patients with symptomatic COPD, therapy with a long-acting anti muscarinic agent/long-acting beta agonist (LAMA/LABA) combination administered by nebulizer will improve hyperinflation (increase in inspiratory capacity and reduction in residual volume) and reduce symptoms related to COPD to a greater extent than LAMA/LABA therapy given by a DPI.

The study aims to demonstrate the following:

1. Compare the values of inspiratory capacity (IC) and residual volume (RV) in patients receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer 2. Compare patient reported outcomes (COPD Assessment Test (CAT score), Baseline/Transition Dyspnea Index (BDI/TDI) and the St. George Respiratory Questionnaire (SGRQ) in symptomatic patients with COPD receiving LAMA/LABA by DPI with those receiving LAMA/LABA by nebulizer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 40 years

Either sex

Current smoker or past cigarette smoking history of > 10 pack-years

Symptoms of COPD (cough, sputum production, shortness of breath)

Disqualifiers

Diagnosis of asthma (Verification via medical record and/or patient report)

Previously diagnosed atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (ventricular tachycardia) (Verification via medical record and/or patient report)

Acute myocardial infarction within 12 weeks of patient study registration (Verification via medical record and/or patient report)

Acute exacerbation of congestive heart failure (Verification via medical record and/or patient report)

Trial design

Design model

Parallel

Treatments tested in this trial

  • umeclidinium 62.5 µg and vilanterol 25 µg

    Drug

    DPI Treatment

  • Revefenacin 175 µg, Formoterol 20 µg

    Drug

    Nebulizer Treatment

  • Placebo ( Revefenacin and Formoterol )

    Drug

    Placebo Nebulizer Treatment

  • Placebo DPI

    Drug

    Placebo DPI Treatment

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: DPI Treatment GroupActive comparator 2 interventions
Group B: Nebulizer Treatment GroupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Difference Between the Values of Area Under the Response Curve for Inspiratory Capacity (IC)

Difference between the values of area under the response curve for inspiratory capacity (IC) from baseline through six hours (AUC IC 0-6h) after inhalation of LAMA/LABA combination with a nebulizer versus a DPI OR Proportion of participants achieving improvement of \>2 points in their CAT score compared to baseline OR Proportion of participants achieving reduction of 4 points in SGRQ score compared to baseline

Time frame
From baseline (Visit 2, Week 2) through study completion (Visit 3, Week 12)

Secondary outcomes

1

Percentage change in Residual Volume (RV) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

Time frame
From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)
2

Percentage change in Total Lung Capacity (TLC) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

Time frame
From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)
3

Percentage change in airway resistance (Raw) from baseline after inhalation of LAMA/LABA combination with a nebulizer versus a DPI

Time frame
From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)
4

Maximum percentage change in inspiratory capacity between 0 and 6 hours after LAMA/LABA combination with a nebulizer versus a DPI

Time frame
From pre-dose (baseline measurement) to post-dose measurements at 1, 2, 4, and 6 hours during study visit 2 (Week 2) and study visit 3 (Week 12)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tennessee Graduate School of Medicine

Lead sponsor

Theravance Biopharma

Collaborator

Source ClinicalTrials.gov
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