Dose of Corticosteroids in COPD

NCT01742338 | Terminated Phase 4 Results

• 1 other identifier: 0220120019
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

Brief Summary

COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Chronic bronchitis; emphysema; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  Composite outcome of treatment failure defined as death, intubation, re-admission for COPD exacerbation, or intensification of therapy (increased steroid use, change of antibiotic therapy) within a 30-day follow-up period.

  30 days

Secondary Outcomes (2)

• Length of Stay

  30 days

• Quality of Life Score

  30 days

Other Outcomes (1)

• Adverse Effects

  30 days

Study Arms (2)

Low Dose Corticosteroids

ACTIVE COMPARATOR

10 mg IV q8hrs x 3 days\*, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop. \*If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days.

Drug: Low Dose Corticosteroids

High Dose Corticosteroids

EXPERIMENTAL

Methylprednisolone 40 mg IV q8hrs x 3 days\*, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. \*If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days.

Drug: High Dose Corticosteroids

Interventions

Low Dose Corticosteroids DRUG

Also known as: prednisone, methylprednisolone, Solumedrol

Low Dose Corticosteroids

High Dose Corticosteroids DRUG

Also known as: prednisone, methylprednisolone, Solumedrol

High Dose Corticosteroids

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital

You may not qualify if:

• i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices.
• vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

University Medical Center at Princeton

Plainsboro, New Jersey, 08536, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

Adrenal Cortex Hormones; Prednisone; Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prednisolone; Pregnadienetriols

Results Point of Contact

• Title: Dr. Jeffrey L. Carson
• Organization: Rutgers Robert Wood Johnson Medical School

jeffrey.carson@rutgers.edu

732-235-7122

Study Officials

• Jeffrey L Carson, MD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: May 3, 2012
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (2)