Trial Outcomes & Findings for A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (NCT NCT00686335)

NCT ID: NCT00686335

Last Updated: 2024-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 4 weeks and 8 weeks
• Results posted on: 2024-12-17

Participant Flow

Asthmatic patients, aged at least 18 years, suffering from severe persistent asthma, having nocturnal symptoms and receiving treatment with oral glucocorticoids were recruited from Hôpital Bichat between July 2008 and March 2010.

After a 4-week run-in period in which patients were treated with immediate release prednisone (Cortancyl®) administered in the morning, all eligible patients (based on inclusion/exclusion criteria) were treated for 4 weeks with an identical dose of Lodotra administered in the evening.

Participant milestones

Measure	Safety Population all patients that started the run-in period with Cortancyl®
Run-in Period STARTED	12
Run-in Period COMPLETED	7
Run-in Period NOT COMPLETED	5
Treatment Period STARTED	7
Treatment Period COMPLETED	7
Treatment Period NOT COMPLETED	0

Reasons for withdrawal

Measure	Safety Population all patients that started the run-in period with Cortancyl®
Run-in Period Adverse Event	1
Run-in Period asthma exacerbation	1
Run-in Period violation of inclusion/exclusion criteri	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Safety Population n=12 Participants all patients that started the run-in period with Cortancyl®
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 14.40 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment France	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks and 8 weeks

Population: The efficacy analysis population included all 7 patients who completed both study periods without major protocol deviations.

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.

Outcome measures

Measure	Lodotra n=7 Participants modified release prednisone	Cortancyl n=7 Participants immediate release prednisone
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment	2.1 number of nocturnal awakenings Standard Deviation 4.41	10.0 number of nocturnal awakenings Standard Deviation 5.45

Adverse Events

Lodotra

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cortancyl

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lodotra n=7 participants at risk modified release prednisone	Cortancyl n=12 participants at risk immediate release prednisone
Respiratory, thoracic and mediastinal disorders asthma	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Vascular disorders arterial thrombosis	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4

Other adverse events

Measure	Lodotra n=7 participants at risk modified release prednisone	Cortancyl n=12 participants at risk immediate release prednisone
Respiratory, thoracic and mediastinal disorders asthma	28.6% 2/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	16.7% 2/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Psychiatric disorders insomnia	28.6% 2/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Musculoskeletal and connective tissue disorders arthralgia	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Respiratory, thoracic and mediastinal disorders cough	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Respiratory, thoracic and mediastinal disorders dyspnoea	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Gastrointestinal disorders hernial eventration	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
General disorders influenza like illness	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Reproductive system and breast disorders menstrual disorder	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
General disorders oedema	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Musculoskeletal and connective tissue disorders pain in extremity	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Nervous system disorders tremor	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Surgical and medical procedures tooth extraction	14.3% 1/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	0.00% 0/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Psychiatric disorders anxiety	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Infections and infestations bronchitis	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	25.0% 3/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Infections and infestations fungal skin infection	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Vascular disorders haematoma	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Musculoskeletal and connective tissue disorders muscle spasms	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4
Infections and infestations sinusitis	0.00% 0/7 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4	8.3% 1/12 • Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later. Safety was evaluated by: * recording of Adverse Events (AEs) and concomitant treatments at each visit * physical examination and vital sign measurements at each visit * laboratory safety assessments at visits V0 and V4

Additional Information

Senior Vice President, Clinical Development & Operations

Horizon Pharma

Phone: 224-383-3012

Email: agrahn@horizonpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Anything concerning publication, information and communication is described under law number R5121-13 of the French Code de la Santé Publique. Any information about results cannot be given without the accordance of Horizon Pharma (formerly Nitec Pharma).
• Publication restrictions are in place

Restriction type: OTHER