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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone group | Active Comparator |
| |
| Dexamethasone group | Active Comparator |
| |
| Prednisolone group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone, Dexamethasone, Prednisolone | Drug | Corticosteroids |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy Cairo University | Cairo | 12411 | Egypt |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D003907 | Dexamethasone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |