Asthma
Conditions
Keywords
asthma, nocturnal asthma, glucocorticoid dependent persistent asthma, signs and symptoms, lung function, prednisone
Brief summary
The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.
Detailed description
Study with completed results acquired from Horizon in 2024.
Interventions
DRUGLodotra
Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period.
DRUGCortancyl
Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject must be able to understand the terms of the written informed consent form, and must provide a dated and signed form before the start of any study procedure * At least 18 years old * Patient having a diagnosis of asthma dating back more than 6 months at the time of inclusion * Asthma necessitating a continuous treatment by oral corticoids * A minimum of 3 nocturnal awakenings due to asthma during the last screening week * Stable dose of oral glucocorticoids for at least 4 weeks prior to inclusion into the study * No change in asthma medication during the last 4 weeks prior to V0 * Non-smoker or ex-smoker (having stopped smoking more than one year previously and with a smoking history of less than 10 pack years ) * Female patients of childbearing potential must be using a medically accepted contraceptive regimen * Able to perform the required study procedures including handling of medication containers and diaries
Exclusion criteria
* Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0: * hospital admission for asthma (including treatment in an emergency room), * a lower airway infection, * Diagnosis of chronic obstructive pulmonary disease or other relevant lung diseases (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, active tuberculosis, interstitial lung disease) * Clinically significant abnormalities of the hematological or biochemical constants * Pregnancy or breastfeeding * Participation in another clinical study within 30 days preceding Visit V0, * Re-entry of patients previously enrolled in this trial, * Suspected inability or unwillingness to comply with the study procedures * Alcohol or drug abuse * Need to take a non-authorised concomitant treatment (cf. list of medicaments not authorised during the study) in the course of the study * Other disease requiring treatment with corticosteroids * Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * Patient with a hospitalisation scheduled during the study period * Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment | 4 weeks and 8 weeks | Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra. |
Countries
France
Participant flow
Recruitment details
Asthmatic patients, aged at least 18 years, suffering from severe persistent asthma, having nocturnal symptoms and receiving treatment with oral glucocorticoids were recruited from Hôpital Bichat between July 2008 and March 2010.
Pre-assignment details
After a 4-week run-in period in which patients were treated with immediate release prednisone (Cortancyl®) administered in the morning, all eligible patients (based on inclusion/exclusion criteria) were treated for 4 weeks with an identical dose of Lodotra administered in the evening.
Participants by arm
| Arm | Count |
|---|---|
| Safety Population all patients that started the run-in period with Cortancyl® | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Run-in Period | Adverse Event | 1 |
| Run-in Period | asthma exacerbation | 1 |
| Run-in Period | violation of inclusion/exclusion criteri | 3 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 48.9 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment France | 12 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 7 | 7 / 12 |
| serious Total, serious adverse events | 0 / 7 | 1 / 12 |
Outcome results
Primary
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.
Time frame: 4 weeks and 8 weeks
Population: The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lodotra | Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment | 2.1 number of nocturnal awakenings | Standard Deviation 4.41 |
| Cortancyl | Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment | 10.0 number of nocturnal awakenings | Standard Deviation 5.45 |
Comparison: As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.95% CI: [-13.5, -2.2]Other