Clinical trial NCT00686335: A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
Official title: A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
nocturnal asthma
glucocorticoid dependent persistent asthma
signs and symptoms
lung function
prednisone
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.)

Primary outcomes:
measure: Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
timeFrame: 4 weeks and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat
Study officials:
affiliation: Amgen
name: Michel MD
role: STUDY_DIRECTOR
References: