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| Sponsor: | Institute of Medicinal Molecular Design, Inc. |
|---|---|
| Information provided by: | Institute of Medicinal Molecular Design, Inc. |
| ClinicalTrials.gov Identifier: | NCT00883584 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: IMD-1041 Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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) |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
IMD-1041
|
Drug: IMD-1041
Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
|
| Placebo Comparator: 2 |
Drug: Placebo
Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| King Edward VII Hospital (Imperial College, London) | |
| Windsor, Berkshire, United Kingdom, SL4 3DP | |
| Medicines Evaluation Unit, Wythenshawe Hospital | |
| Manchester, United Kingdom, M23 9QZ | |
| Principal Investigator: | Paul Ford, MB, BS, MRCP, PhD | King Edward VII Hospital, Windsor, Berkshire, SL4 3DP, UK |
More Information
| Responsible Party: | Covance CRU Ltd. (Sacha Webber-Cross - Project Manager), Covance CRU Ltd. |
| ClinicalTrials.gov Identifier: | NCT00883584 History of Changes |
| Other Study ID Numbers: | IMD-10412003-1 |
| Study First Received: | April 16, 2009 |
| Last Updated: | April 22, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Proof of Concept Inflammatory Markers Lung Function Chronic Obstructive Pulmonary Disease COPD |
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |