Interstitial Lung DiseaseNCT04982809
Cost-effectiveness Analysis of Three Corticosteroids in ILDs
A study testing Betamethasone, Dexamethasone, Prednisolone in people with Interstitial Lung Disease, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Betamethasone, Dexamethasone, Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Parameters Used to Measure Effectiveness as KL-6, PFTs, ESR, CRP
- 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- Betamethasone, Dexamethasone, Prednisolone
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone, Dexamethasone, PrednisoloneDrug
Corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone group | Active comparator | Not described Receives: Drug: Betamethasone, Dexamethasone, Prednisolone |
| Dexamethasone group | Active comparator | Not described Receives: Drug: Betamethasone, Dexamethasone, Prednisolone |
| Prednisolone group | Active comparator | Not described Receives: Drug: Betamethasone, Dexamethasone, Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
Respiratory Function Assessment; FEV1
FEV1: Forced expiratory volume in the 1st second, measured in (% predicted) using a spirometer
Measured: 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.
Measured: 3 months
Respiratory Function Assessment; FEV/FVC Ratio
FEV/FVC: The ratio between the above 2 outcomes
Measured: 3 months
Respiratory Function Assessment; 6MWD
6MWD: the distance walked by the patient after 6 minutes (measured in meters).
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Jul 2018
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa G. Elhennawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982809
- Sponsor's protocol ID
- CL (2183)
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Pharmacoeconomic Study of Using Different Corticosteroids in the Treatment of Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT04982809
- Acronym / sponsor ID
- CL (2183)
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- Parameters Used to Measure Effectiveness as KL-6, PFTs, ESR, CRP
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betamethasone group | Active comparator | Drug: Betamethasone, Dexamethasone, Prednisolone |
| Dexamethasone group | Active comparator | Drug: Betamethasone, Dexamethasone, Prednisolone |
| Prednisolone group | Active comparator | Drug: Betamethasone, Dexamethasone, Prednisolone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethasone, Dexamethasone, PrednisoloneCorticosteroids | Drug | Betamethasone group, Dexamethasone group, Prednisolone group |
Primary outcome
Krebs von den Lungen - 6 (KL-6)
Time frame: 3 months
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
5 secondary outcomes
Respiratory Function Assessment; FEV1
Time frame: 3 months
Respiratory Function Assessment; FVC
Time frame: 3 months
Respiratory Function Assessment; FEV/FVC Ratio
Time frame: 3 months
Respiratory Function Assessment; 6MWD
Time frame: 3 months
Respiratory Function Assessment; % O2 desaturation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease
RecruitingPhase 2
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
Active, not recruitingObservational study
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Pulmonary Hypertension, Interstitial Lung Disease
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone, Dexamethasone, Prednisolone in people with Interstitial Lung Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Krebs von den Lungen - 6 (KL-6) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.