Cost-effectiveness Analysis of Three Corticosteroids in ILDs

Effectiveness and Pharmacoeconomic Study of Using Different Corticosteroids in the Treatment of Interstitial Lung Diseases

This was a 3 months prospective, open label, and parallel study to test the efficacy of 3 different corticosteroids in the management of interstitial lung diseases. Followed by a pharmacoeconomic analysis to find which regimen (betamethasone, dexamethasone or prednisolone) is the most cost-effective.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Drug: Betamethasone, Dexamethasone, Prednisolone

Detailed Description

Three different corticosteroid regimens were evaluated for the management of interstitial lung diseases (ILDs) with specific focus on hypersensitivity pneumonitis (HP) where the patients were divided into 3 treatment groups:

• Group I: patients receiving weekly pulse doses of betamethasone IM injection (equivalent dose to that of prednisolone daily dose in a week).
• Group II: patients receiving weekly pulse doses of dexamethasone IV injection (equivalent dose to that of prednisolone daily dose in a week).

• Group III: patients receiving oral prednisolone daily (dose range 15-20 mg/day).

  10 mg oral prednisolone oral ≡ 1.5 mg dexamethasone intravenous ≡ 1.2 mg betamethasone intramuscular.

After the administration of the above-mentioned medications, the patients were followed-up over 3 months to evaluate their disease progression. Informed consent was obtained from all subjects or their surrogate after explanation and understanding of the nature, purpose, and potential risks of the study. The study protocol was approved by the Ethics Committee, Faculty of Pharmacy, Cairo University (protocol serial number: CL (2183)) .

A special patient information sheet was designed to collect all information required for data analysis. The sheet was designed to be divided into several sections:

1. Demographic Data The first section of the patients' information sheet was designed to accommodate the basic general and demographic data (name, address, age, telephone number, social status, weight, and height of the patient). These details were documented from the patient's medical notes.
2. Medical Data Medical records were used to obtain other data including date and time of examination, the diagnosis, medications on recruitment (if any), smoking habits, patient's medical history, in addition to the patient's medication history.
3. Parameters Used to Measure Effectiveness as KL-6, PFTs, ESR, CRP
4. Parameters to Evaluate Treatment Safety Liver Function Tests, Random Blood Glucose (RBG), Blood Pressure

Cost Effectiveness Analysis The study is designed from patient perspective where the direct medical costs as well as the indirect costs (e.g., loss of patients' income) are studied. The costs are collected directly from the patient prospectively throughout the study period. All costs were actual covering the treatment expenses as: the cost of the medications, the cost of administration, the cost of the hospital stay due to ILD during the study period, the cost of the physician's visit and the cost afforded by the patient in order to administer the recommended medication, any extra costs due to exacerbations or adverse effects due to the use of corticosteroids and costs of transportation and days-off.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12411
    • faculty of pharmacy Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with ILD (hypersensitivity pneumonitis) with age between18 and 65 years old.
• Symptoms including dry cough and shortness of breath.
• Significant decrease in pulmonary function (desaturation by 4% after 6-minute walk distance), where the patients were no more controlled on their prednisolone maintenance therapy (up to 10 mg/day).
• Chest CT showing ground glass opacity and band of shadow.

Exclusion Criteria:

• Patients with any other organ affliction (heart failure (ejection fraction 40-50%), renal failure (decrease in glomerular filtration rate > 75%), or liver cirrhosis (transient elastography liver stiffness measurements 12.5-75.5 kPa)).
• Active infection.
• Patients on other immunosuppressive medications (e.g., cyclophosphamide) and anti-fibrotic (e.g., interferon, pirfenidone, endothelin-1 antagonist and tumor necrosis factor α modulator).
• History of pulmonary embolism (corticosteroids' use increase the risk of recurrence of pulmonary embolism).
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betamethasone group	Drug: Betamethasone, Dexamethasone, Prednisolone; Corticosteroids
Active Comparator: Dexamethasone group	Drug: Betamethasone, Dexamethasone, Prednisolone; Corticosteroids
Active Comparator: Prednisolone group	Drug: Betamethasone, Dexamethasone, Prednisolone; Corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Krebs von den Lungen - 6 (KL-6)	a high molecular weight mucin-like glycoprotein expressed on cell surface of alveolar epithelial cells. Elevated levels of KL-6 occur in ILDs and it is recently widely accepted as a biomarker for diagnosis and prognosis of ILDs. Measured as (U/ml) using ELISA	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Function Assessment; FEV1	FEV1: Forced expiratory volume in the 1st second, measured in (% predicted) using a spirometer	3 months
Respiratory Function Assessment; FVC	FVC: Forced Vital Capacity which is the capacity of the lung to air volume, measured in (% predicted) using spirometer.	3 months
Respiratory Function Assessment; FEV/FVC Ratio	FEV/FVC: The ratio between the above 2 outcomes	3 months
Respiratory Function Assessment; 6MWD	6MWD: the distance walked by the patient after 6 minutes (measured in meters).	3 months
Respiratory Function Assessment; % O2 desaturation	% O2 desaturation: the amount of oxygen desaturation that occurs after walking for 6 minutes, measured as the difference between Spo2 before and after the patient walks for 6 minutes (% of oxygen saturation).	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Prednisolone; Betamethasone
• Other Study ID Numbers: CL (2183)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No