Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04982809 |
| Other study ID # |
CL (2183) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
March 15, 2020 |
Study information
| Verified date |
July 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
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.
