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NCT Number: NCT03324607

Effects of Bevespi on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

About this study

The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.

The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) < 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second [FEV1] < 80%)
  • Willing and able to give informed consent and adhere to visit/protocol schedules
  • Women of childbearing potential must have a negative urine pregnancy test

Exclusion criteria

  • Upper respiratory tract infection within 6 weeks
  • Chronic systemic corticosteroid use > 10 mg/day of prednisone
  • Chronic oxygen use (intermittent or continuous)
  • Previous lung resection surgery or decortication
  • Previous history of pneumothorax
  • Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
  • History of exposure to occupational or environmental hazards that are known to cause lung diseases
  • For women of child bearing potential, positive pregnancy test
  • Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
  • Patients who are not willing to withhold COPD inhalers for the run-in period.
  • MRI is contraindicated based on responses to MRI screening questionnaire
  • Subject is pregnant or lactating
  • Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  • Subject has any form of known cardiac arrhythmia
  • Subject does not fit into 129Xe vest coil used for MRI
  • Subject cannot hold his/her breath for 15 seconds
  • Subject deemed unlikely to be able to comply with instructions during imaging

Treatment and study plan

hyperpolarized 129Xe gas MRI

Drug

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.

Other names: 129Xe MRI

Bevespi Aerosphere

Drug

There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.

Other names: Inhaler

Primary outcomes

  1. Ventilation Distribution as Measured by Ventilation Defect+Low Percent

    Time frame: Week 2

    The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air.

  2. Barrier Uptake.

    Time frame: 2 weeks

    Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood.

  3. Red Blood Cell (RBC) Uptake

    Time frame: 2 weeks

    Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane

Secondary outcomes

  1. Pulmonary Function Test - Forced Vital Capacity (FVC)

    Time frame: 2 weeks

    Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry.

  2. Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)

    Time frame: 2 weeks

    FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second.

  3. Pulmonary Function Test - Total Lung Capacity (TLC)

    Time frame: 2 weeks

    Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation.

  4. Pulmonary Function Test - Residual Volume (RV)

    Time frame: 2 weeks

    Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation.

  5. Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

    Time frame: 2 weeks

    DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream.

  6. 6-minute Walk Test (6MWT)

    Time frame: 2 weeks

    The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes.

  7. St. George's Respiratory Questionnaire (SGRQ) Score

    Time frame: 2 weeks

    The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

  8. Rating of Perceived Dyspnea (RPD) Scale

    Time frame: 2 weeks

    A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity).

  9. COPD Assessment Test (CAT) Score

    Time frame: 2 weeks

    Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

Sponsors and collaborators

Lead sponsor

Bastiaan Driehuys

Other

Registry information

Official study title

Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI

Acronym: COPD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2017
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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