Status:
COMPLETED
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
Lead Sponsor:
Amgen
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00686335
Start Date
June 1 2008
End Date
May 1 2010
Last Update
December 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Bichat
Paris, France, 75018