A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (NCT00686335) | Clinical Trial Compass
CompletedPhase 2
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
France12 participantsStarted 2008-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 bio…
What they're measuring
1
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment