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

NCT00686335 | Completed Phase 2 Results

• 2 other identifiers: NP01-201EudraCT-Number: 2007-007316-29
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; nocturnal asthma; glucocorticoid dependent persistent asthma; signs and symptoms; lung function; prednisone

Outcome Measures

Primary Outcomes (1)

• Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment

  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.

  4 weeks and 8 weeks

Study Arms (2)

Lodotra

EXPERIMENTAL

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

Cortancyl

ACTIVE COMPARATOR

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

Interventions

Lodotra DRUG

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.

Also known as: modified release tablet formulation of prednisone

Lodotra

Cortancyl DRUG

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).

Also known as: immediate release prednisone tablets

Cortancyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Asthma necessitating a continuous treatment by oral corticoids
• A minimum of 3 nocturnal awakenings due to asthma during the last screening week
• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Hôpital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Asthma; Signs and Symptoms

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This was an explorative study to collect data for a subsequent controlled trial and therefore no hypothesis testing was performed. The size of the efficacy population (N=7) is too small to detect any statistically significant changes.

Results Point of Contact

• Title: Senior Vice President, Clinical Development & Operations
• Organization: Horizon Pharma

agrahn@horizonpharma.com

224-383-3012

Study Officials

• Michel MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2008
• First Posted: May 29, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 17, 2024
• Results First Posted: December 28, 2012

Record last verified: 2024-11

Locations

FR (1)