AsthmaPhase 2MONANCT00686335
A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
A Phase 2 study testing Lodotra and Cortancyl in people with Asthma, run by Amgen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Lodotra and Cortancyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Study with completed results acquired from Horizon in 2024.
- Conditions
- Asthma
- Being tested
- Lodotra, Cortancyl
- Keywords
- asthma, nocturnal asthma, glucocorticoid dependent persistent asthma, signs and symptoms, lung function, prednisone
- Medical subject headings
- Asthma, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LodotraDrug
Also called modified release tablet formulation of prednisone
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.
CortancylDrug
Also called immediate release prednisone tablets
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cortancyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686335
- Sponsor's protocol ID
- NP01-201
- Other IDs
- EudraCT-Number: 2007-007316-29
- Acronym
- MONA
- Status last verified
- Nov 2024
- First submitted
- 26 May 2008
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
- ClinicalTrials.gov ID
- NCT00686335
- Acronym / sponsor ID
- MONA / NP01-201
- Conditions
- Asthma
- Keywords
- asthma, nocturnal asthma, glucocorticoid dependent persistent asthma, signs and symptoms, lung function, prednisone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 May 2008 (estimated)
- Results
- Posted 28 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study with completed results acquired from Horizon in 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lodotra | Experimental | Drug: LodotraAfter 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. |
| Cortancyl | Active comparator | Drug: CortancylDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LodotraAlso: modified release tablet formulation of prednisoneAdministered 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. | Drug | Lodotra |
| CortancylAlso: immediate release prednisone tabletsAdministered 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). | Drug | Cortancyl |
Primary outcome
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
Time frame: 4 weeks and 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lodotra and Cortancyl in people with Asthma, run by Amgen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment (time frame: 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.