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A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier:
NCT00686335
First received: May 26, 2008
Last updated: November 27, 2012
Last verified: November 2012
  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 Ireland, Ltd., Dublin Ireland:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686335

Locations
France
Hôpital Bichat
Paris, France, 75018
Sponsors and Collaborators
Horizon Pharma Ireland, Ltd., Dublin Ireland
Investigators
Principal Investigator: Michel Aubier, Prof. Dr. Hôpital Bichat, Paris, France
  More Information

No publications provided

Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
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 Ireland, Ltd., Dublin Ireland:
asthma
nocturnal asthma
glucocorticoid dependent persistent asthma
signs and symptoms
lung function
prednisone

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014