Chronic Obstructive Pulmonary DiseasePhase 2COPDNCT00883584
IMD-1041 Chronic Obstructive Pulmonary Disease: Proof of Concept (POC) Study
A Phase 2 study testing IMD-1041 in people with Chronic Obstructive Pulmonary Disease, run by Institute of Medicinal Molecular Design, Inc. at 2 sites in United Kingdom.
Trial summary
COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the airways/tubes that carry air in and out of the lungs are partly obstructed, making it difficult to get air in and out. COPD gets gradually worse over time. At the moment there is no cure for COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- IMD-1041
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females aged 40 to 80 years of age at the time of the screening visit. (Women of childbearing potential will be allowed to enter the trial only if they are using one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit and week 12 (Visit 3)
- Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction
- Patients with a post salbutamol FEV1 ≥ 30% of the predicted value, < 80% of the predicted value (i.e., 30% ≤ 100 x observed post-salbutamol FEV1/predicted FEV1 <80%) or who is deemed suitable by the Investigator (at either screening or baseline)
- Post-salbutamol FEV1/forced vital capacity (FVC) <70% (i.e,. 100 x post-salbutamol FEV1/FVC <70%)
- Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years
- Patients who have the ability to produce a viable sputum sample (≤ 50% squamous cells)
- Predominant current diagnosis of smoking related COPD
- Patients who were eligible and able to participate in the trial and who consented to do so in writing after the purpose and nature of the investigation had been explained to them
Who cannot join
- History or current diagnosis of asthma, allergic rhinitis or atopy. N.B. Misdiagnosed asthma or childhood asthma is acceptable, however must be confirmed by the Investigator
- Eosinophil count >600 cells/mm3
- A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit
- Patients who have been hospitalised for an acute COPD exacerbation in the 12 months or an exacerbation in the last 3 months which was treated with oral steroids prior to the screening visit
- Use of long-term oxygen therapy (≥15 hours/day)
- Clinically significant respiratory conditions defined as: Known active tuberculosis, History of interstitial lung or pulmonary thromboembolic disease, Pulmonary resection during the past 12 months, History of life-threatening COPD, History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener's syndrome, etc), Patients who in the Investigator's opinion may need pulmonary rehabilitation or a thoracotomy during the trial
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- Clinically significant cardiovascular conditions defined as: Myocardial infarction during the last 6 months, Unstable arrhythmia which required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months, Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association
- Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the Investigator, which could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period
- Patients who are not able to perform reproducible spirometry attempts at the screening visit or during the repeat at baseline
- Clinically relevant abnormalities in the results of laboratory, ECG parameters (QTc > 470 milliseconds), or physical examination at the screening evaluation if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD
- Patients with a history of drug and/or alcohol abuse that may prevent compliance with trial activities
- Treatment with any IMP within 3 month prior to screening visit
- Changes to any concomitant therapy either for COPD or any other well-controlled illness within 1 month prior to screening visit
- Treatment with a prohibited medication as detailed in Section 5.8
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester, M23 9QZ
King Edward VII Hospital (Imperial College, London)
Windsor, Berkshire, SL4 3DP
About this study
Official title: A Phase IIa, Proof of Concept Study to Evaluate the Reduction in Inflammatory Biomarkers and Assess Airway Function Following Administration of IMD-1041 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the airways/tubes that carry air in and out of the lungs are partly obstructed, making it difficult to get air in and out. COPD gets gradually worse over time. At the moment there is no cure for COPD. The best way to slow the disease is to stop smoking. Current medications are used to alleviate shortness of breath and cough, and to treat infections of the lungs that can worsen COPD.
Institute of Medicinal Molecular Design, Inc. (IMMD), a Japanese Drug Discovery Company is developing a compound code named IMD-1041. IMD-1041 is an investigational drug, meaning it is not yet on the market. It is an IKKb inhibitor developed for the treatment of COPD. Unlike most other medications used for COPD currently, IMD-1041 is in capsule form and needs to be taken twice a day. It is also unlike all other drugs in use because it treats the underlying cause of the symptoms.
The purpose of this study is to see if IMD-1041 has the ability to reduce inflammatory derived symptoms and airway remodelling (changes) by looking at certain changes in chemical levels in the blood and sputum (phlegm).
Read the detailed description
The dose level of IMD 1041 has been selected based on previous clinical trials. The dose to be studied, 400mg, is considered to be efficacious, and is supported by the clinical data in healthy subjects and type 2 diabetic patients.
Single oral doses of 800 mg and multiple oral doses of 400 mg twice daily of IMD-1041 have been shown to be safe and well tolerated by healthy subjects.
Twice daily doses of 200 mg of IMD-1041 have been shown to be safe and well tolerated when given to diabetic patients for 12 weeks.
A placebo (dummy medication) arm has been selected as it is considered the most reliable method to minimise patient and investigator bias and current COPD guidelines suggest the most useful comparison would be with placebo. Exposure placebo will allow a reliable evaluation of IMD 1041, as well as the adverse events caused by the drug compared to those resulting from the COPD natural course.
All patients will be able to remain on the current medications apart from theophylline which is expected to have effects on IKK beta.
The current treatments for COPD do not include a medication of this mechanism of action, who's main aim is to reduce inflammatory and fibrotic changes which cause the symptoms which current standard COPD medications treat.
The study will last for 12-14 weeks, including a 7 day screening period, visit 0 baseline/randomisation visit, visit 1 and visit 3 for all study spec tests, visit 2 and 4/follow up as either a site or telephone contact to check subject compliance and adverse events.
Prior to selection the Investigator will evaluate the eligibility of patients for entry into the trial by reviewing the patients' medical records against the inclusion/exclusion criteria specified in the protocol.
There will be a potential pre-screening visit up to 3 weeks prior to randomisation. This visit will only be applicable for patients who need to stop the medication theophylline which need to be stopped 2 weeks prior to screening. At this visit potential patients will be provided with the information about study activities and requirements. After signing the informed consent form the patient will be asked to stop the medication and return to the study site for screening at least 2 weeks after the visit.
All patients will attend the clinical site for initial screening up to 7 days prior to randomisation. If the patient has not been 'pre-screened' as described above, they will be given information pertaining to study activities and requirements. After signing the informed consent form evaluations will be performed to confirm the patients' eligibility according to the study protocol. The patients' medical history, physical examination, clinical laboratory tests, electrocardiogram (ECG) tracing, blood pressure, pregnancy screening (women of child bearing potential only) will be performed. Blood will be taken for routine clinical laboratory testing.
Following successful screening, patients will return to the site up to seven days (but at least 1 day) after the screening visit for randomisation. There will be a 50:50 chance of the patient being randomised to either IMD 1041 or placebo of whichever they will remain on for the duration of the study. The following will then happen prior to randomisation:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- Vitals signs
- Blood will be taken for clinical lab evaluations and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- 2 questionnaires completed Following all of the above evaluations the patient will be randomised and medication dispensed. (A total of 280 tablets will be dispensed, which equates to 4 weeks supply, plus 56 tablets as spares in case of loss or delayed next visit.)
Visit 1 will occur 4 weeks after visit 0 (+/- 2 days). At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- vitals signs
- Blood will be taken for clinical lab evaluations, PK analysis and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- Medication will be dispensed. A total of either 4(224) or 8(448) weeks supply will be dispensed depending on whether or not you will attend the clinical site for visit 3.
Visit 2 will occur 4 weeks after visit 1 (+/- 3 days). This visit will be either on site or over the telephone and will be decided by the Principal Investigator on a case-by-case basis. At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- Medication dispensed. A total of 4 weeks supply (224 tablets) will be dispensed for patients who attend the site for this visit.
Visit 3 will occur up to 4 weeks after visit 2 (+/- 3 days). At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- vitals signs
- Blood will be taken for clinical lab evaluations, PK analysis and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- 2 questionnaires completed
- All medication return and final accountability documented
Visit 4, the follow up visit will be via telephone and will occur 2 weeks after visit 3 (+/- 3 days). The following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- IMD-1041, Placebo
- Keywords
- Proof of Concept, Inflammatory Markers, Lung Function, Chronic Obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMD-1041Drug
Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
PlaceboDrug
Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IMD-1041 Receives: Drug: IMD-1041 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of IMD-1041 to reduce levels of IL-1β, IL-6, TNF-α and GRO-α in blood and/or sputum
Measured: 10-12 months
Secondary outcomes (1)
PAI-1 in induced sputum and PAI-1 and t-PA-PAI complex in blood. Levels of CCL5, IL-8, MMP9, TIMP1, MCP-1 and MPO in induced sputum and/or blood
Measured: 10-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJul 2008
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Medicinal Molecular Design, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Ford, MB, BS, MRCP, PhD, Principal investigator, King Edward VII Hospital, Windsor, Berkshire, SL4 3DP, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883584
- Sponsor's protocol ID
- IMD-10412003-1
- Acronym
- COPD
- Status last verified
- Apr 2009
- First submitted
- 16 Apr 2009
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Proof of Concept Study to Evaluate the Reduction in Inflammatory Biomarkers and Assess Airway Function Following Administration of IMD-1041 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00883584
- Acronym / sponsor ID
- COPD / IMD-10412003-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Proof of Concept, Inflammatory Markers, Lung Function, Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Medicinal Molecular Design, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the airways/tubes that carry air in and out of the lungs are partly obstructed, making it difficult to get air in and out. COPD gets gradually worse over time. At the moment there is no cure for COPD. The best way to slow the disease is to stop smoking. Current medications are used to alleviate shortness of breath and cough, and to treat infections of the lungs that can worsen COPD.
Institute of Medicinal Molecular Design, Inc. (IMMD), a Japanese Drug Discovery Company is developing a compound code named IMD-1041. IMD-1041 is an investigational drug, meaning it is not yet on the market. It is an IKKb inhibitor developed for the treatment of COPD. Unlike most other medications used for COPD currently, IMD-1041 is in capsule form and needs to be taken twice a day. It is also unlike all other drugs in use because it treats the underlying cause of the symptoms.
The purpose of this study is to see if IMD-1041 has the ability to reduce inflammatory derived symptoms and airway remodelling (changes) by looking at certain changes in chemical levels in the blood and sputum (phlegm).
Detailed description
The dose level of IMD 1041 has been selected based on previous clinical trials. The dose to be studied, 400mg, is considered to be efficacious, and is supported by the clinical data in healthy subjects and type 2 diabetic patients.
Single oral doses of 800 mg and multiple oral doses of 400 mg twice daily of IMD-1041 have been shown to be safe and well tolerated by healthy subjects.
Twice daily doses of 200 mg of IMD-1041 have been shown to be safe and well tolerated when given to diabetic patients for 12 weeks.
A placebo (dummy medication) arm has been selected as it is considered the most reliable method to minimise patient and investigator bias and current COPD guidelines suggest the most useful comparison would be with placebo. Exposure placebo will allow a reliable evaluation of IMD 1041, as well as the adverse events caused by the drug compared to those resulting from the COPD natural course.
All patients will be able to remain on the current medications apart from theophylline which is expected to have effects on IKK beta.
The current treatments for COPD do not include a medication of this mechanism of action, who's main aim is to reduce inflammatory and fibrotic changes which cause the symptoms which current standard COPD medications treat.
The study will last for 12-14 weeks, including a 7 day screening period, visit 0 baseline/randomisation visit, visit 1 and visit 3 for all study spec tests, visit 2 and 4/follow up as either a site or telephone contact to check subject compliance and adverse events.
Prior to selection the Investigator will evaluate the eligibility of patients for entry into the trial by reviewing the patients' medical records against the inclusion/exclusion criteria specified in the protocol.
There will be a potential pre-screening visit up to 3 weeks prior to randomisation. This visit will only be applicable for patients who need to stop the medication theophylline which need to be stopped 2 weeks prior to screening. At this visit potential patients will be provided with the information about study activities and requirements. After signing the informed consent form the patient will be asked to stop the medication and return to the study site for screening at least 2 weeks after the visit.
All patients will attend the clinical site for initial screening up to 7 days prior to randomisation. If the patient has not been 'pre-screened' as described above, they will be given information pertaining to study activities and requirements. After signing the informed consent form evaluations will be performed to confirm the patients' eligibility according to the study protocol. The patients' medical history, physical examination, clinical laboratory tests, electrocardiogram (ECG) tracing, blood pressure, pregnancy screening (women of child bearing potential only) will be performed. Blood will be taken for routine clinical laboratory testing.
Following successful screening, patients will return to the site up to seven days (but at least 1 day) after the screening visit for randomisation. There will be a 50:50 chance of the patient being randomised to either IMD 1041 or placebo of whichever they will remain on for the duration of the study. The following will then happen prior to randomisation:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- Vitals signs
- Blood will be taken for clinical lab evaluations and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- 2 questionnaires completed Following all of the above evaluations the patient will be randomised and medication dispensed. (A total of 280 tablets will be dispensed, which equates to 4 weeks supply, plus 56 tablets as spares in case of loss or delayed next visit.)
Visit 1 will occur 4 weeks after visit 0 (+/- 2 days). At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- vitals signs
- Blood will be taken for clinical lab evaluations, PK analysis and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- Medication will be dispensed. A total of either 4(224) or 8(448) weeks supply will be dispensed depending on whether or not you will attend the clinical site for visit 3.
Visit 2 will occur 4 weeks after visit 1 (+/- 3 days). This visit will be either on site or over the telephone and will be decided by the Principal Investigator on a case-by-case basis. At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- Medication dispensed. A total of 4 weeks supply (224 tablets) will be dispensed for patients who attend the site for this visit.
Visit 3 will occur up to 4 weeks after visit 2 (+/- 3 days). At this visit the following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
- vitals signs
- Blood will be taken for clinical lab evaluations, PK analysis and biomarker sampling
- Lung functions
- Induced sputum for biomarker sampling
- 2 questionnaires completed
- All medication return and final accountability documented
Visit 4, the follow up visit will be via telephone and will occur 2 weeks after visit 3 (+/- 3 days). The following will occur:
- Patient asked about current health problems, adverse events and any changes to concomitant medications since screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: IMD-1041IMD-1041 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and non-pregnant, non-lactating females aged 40 to 80 years of age at the time of the screening visit. (Women of childbearing potential will be allowed to enter the trial only if they are using one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit and week 12 (Visit 3)
- Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction
- Patients with a post salbutamol FEV1 ≥ 30% of the predicted value, < 80% of the predicted value (i.e., 30% ≤ 100 x observed post-salbutamol FEV1/predicted FEV1 <80%) or who is deemed suitable by the Investigator (at either screening or baseline)
- Post-salbutamol FEV1/forced vital capacity (FVC) <70% (i.e,. 100 x post-salbutamol FEV1/FVC <70%)
- Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years
Key exclusion criteria (14 listed)
- History or current diagnosis of asthma, allergic rhinitis or atopy. N.B. Misdiagnosed asthma or childhood asthma is acceptable, however must be confirmed by the Investigator
- Eosinophil count >600 cells/mm3
- A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit
- Patients who have been hospitalised for an acute COPD exacerbation in the 12 months or an exacerbation in the last 3 months which was treated with oral steroids prior to the screening visit
- Use of long-term oxygen therapy (≥15 hours/day)
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 |
|---|---|---|
| IMD-1041Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks | Drug | 1 |
| PlaceboCapsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks | Drug | 2 |
Primary outcome
To assess the ability of IMD-1041 to reduce levels of IL-1β, IL-6, TNF-α and GRO-α in blood and/or sputum
Time frame: 10-12 months
1 secondary outcome
PAI-1 in induced sputum and PAI-1 and t-PA-PAI complex in blood. Levels of CCL5, IL-8, MMP9, TIMP1, MCP-1 and MPO in induced sputum and/or blood
Time frame: 10-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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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.
Paul Ford, MB, BS, MRCP, PhD principal investigator
King Edward VII Hospital, Windsor, Berkshire, SL4 3DP, UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMD-1041 in people with Chronic Obstructive Pulmonary Disease, run by Institute of Medicinal Molecular Design, Inc. at 2 sites in United Kingdom.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
To assess the ability of IMD-1041 to reduce levels of IL-1β, IL-6, TNF-α and GRO-α in blood and/or sputum (time frame: 10-12 months). 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 23 Apr 2009.