Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03680495

Conditions

COPD

Emphysema or COPD

COPD Exacerbation

COPD Exacerbation Acute

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Study Details

Brief summary:

Chronic obstructive pulmonary disease (COPD) is a lung disease caused by cigarette smoke that affects millions of people. In the United States, COPD is the 3rd leading cause of death making it one of our most important public health problems. Some people with COPD get disease flares that are called acute exacerbations of COPD - or AECOPDs for short. When people get an AECOPD they experience increased shortness of breath, wheezing and cough; symptoms that often require urgent or emergent treatment by healthcare providers. In the most severe, life-threatening situations, people with AECOPDs are put on a ventilator in the emergency department and admitted to the intensive care unit. Most AECOPDs can be treated with low doses of medications called steroids. This is good because high doses of steroids can cause unwanted side effects. Unfortunately, recent studies suggest that the sickest people, those admitted to the intensive care unit needing ventilator support, need higher doses of steroids because they may have resistance to these important medications. The investigators are studying steroid resistance during very severe AECOPDs so that we can eventually develop better and safer therapies for these vulnerable people.

Conditions

COPD

Emphysema or COPD

COPD Exacerbation

COPD Exacerbation Acute

Respiratory Failure

Study ID

NCT03680495

Start date

Jul 21, 2017

Status verified date

Jan, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria for AECOPD with Ventilatory Failure Cohort:

  • Emergency Department (ED) or ICU physician diagnosis of an acute exacerbation of COPD
  • Age ≥ 40 years of age
  • Need for ventilator support in the ED or ICU during the first 24 hours

Inclusion Criteria for Stable COPD Cohort:

  • Physician diagnosis of COPD
  • Age ≥ 40 years of age
  • Frequency matched to AECOPD subjects for:

  • Age (± 10 year increments)
  • Current/Former smoking status (former smoker = no smoking for ≥ 1 month)
  • Lung function (FEV1% predicted by ± 10% increments)

Exclusion Criteria for AECOPD with Ventilatory Failure Cohort:

  • Systemic steroid use ≤ 30 days prior to return visit
  • Infection requiring antibiotics ≤ 1 month prior to return visit
  • Hemoglobin < 8.0 g/dl
  • Acute pulmonary embolism
  • Diabetes
  • History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation
  • Tracheostomy
  • Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics)
  • Age ≥ 90 year of age
  • Known pregnancy
  • Nursing mothers
  • Prisoners

Exclusion Criteria for Stable COPD Cohort:

  • Systemic steroid use ≤ 30 days prior to return visit
  • Infection requiring antibiotics ≤ 1 month prior to return visit
  • Hemoglobin < 8.0 g/dl
  • Acute pulmonary embolism
  • Diabetes
  • History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation
  • Tracheostomy
  • Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics)
  • Age ≥ 90 year of age
  • Known pregnancy
  • Nursing mothers
  • Prisoners

Study Design

Enrollment

46 participants

Anticipated

Interventions and Outcome Measures

Arms

AECOPD with Respiratory Failure

The AECOPD cohort will be hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with respiratory failure requiring invasive or non-invasive mechanical ventilation. We will be following patients from admission through to discharge, and during a follow-up visit (\~2 months from discharge). During the follow-up visit we will be administering 60mg of methylprednisolone once to study possible steroid resistance.

Stable COPD

The Stable COPD cohort will not have had an AECOPD within the past 6 months and will be frequency matched to the AECOPD cohort. The Stable COPD cohort will have one research visit where we will administer 60mg of methylprednisolone once to study possible steroid resistance.

Interventions

Methylprednisolone

1. Methylprednisolone is a steroid (corticosteroid) similar to a product produced in the adrenal glands. It is used to help relieve inflammation (swelling, heat, redness, and pain) and is used to treat certain medical issues including COPD.

Primary outcome measure

  • Presence of steroid resistance in patients recently admitted with an acute exacerbation of chronic obstructive pulmonary disease with respiratory failure. [ Time Frame: Once at ≥ 45 days after hospital discharge ]

Central Contacts and Locations

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Keywords

  • COPD
  • Steroid Resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2020-01-18.