A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)
This study has been completed.
Sponsor:
Horizon Pharma, Inc.
Information provided by (Responsible Party):
Horizon Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00686335
First received: May 26, 2008
Last updated: November 27, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Lodotra Drug: Cortancyl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma |
Resource links provided by NLM:
Further study details as provided by Horizon Pharma, Inc.:
Primary Outcome Measures:
- Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 12 |
| Study Start Date: | June 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lodotra
After the 4 week run-in period with immediate release prednisone (Cortancyl), patients were switched to the identical dose of modified release prednisone tablets (Lodotra). Study medication for the Lodotra treatment period consisted of Lodotra in 2 dose strengths (5 mg and 1 mg prednisone per tablet). Patients were to take their tablets with or after the evening meal (at 10 pm +/- 30 minutes) for 4 weeks.
|
Drug: Lodotra
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.
Other Name: modified release tablet formulation of prednisone
|
|
Active Comparator: Cortancyl
During the 4 week run-in period, patients remained on their respective pre-study dose of prednisone or equivalent. However, patients were standardized to 5 mg and 1 mg tablets of immediate release prednisone (Cortancyl). Patients were to take their tablets with or after the morning meal (at 8am +/- 30 minutes) for 4 weeks.
|
Drug: Cortancyl
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).
Other Name: immediate release prednisone tablets
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Horizon Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00686335 History of Changes |
| Other Study ID Numbers: | NP01-201, EudraCT-Number: 2007-007316-29 |
| Study First Received: | May 26, 2008 |
| Results First Received: | October 26, 2012 |
| Last Updated: | November 27, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Horizon Pharma, Inc.:
|
asthma nocturnal asthma glucocorticoid dependent persistent asthma |
signs and symptoms lung function prednisone |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Prednisone |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013