IMD-1041 Chronic Obstructive Pulmonary Disease: Proof of Concept (POC) Study

NCT00883584 | Unknown Phase 2

• 1 other identifier: IMD-10412003-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Proof of Concept; Inflammatory Markers; Lung Function; Chronic Obstructive Pulmonary Disease; COPD

Outcome Measures

Primary Outcomes (1)

• 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

  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

  10-12 months

Study Arms (2)

1

ACTIVE COMPARATOR

IMD-1041

Drug: IMD-1041

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMD-1041 DRUG

Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks

1

Placebo DRUG

Capsule 4 x 100mg BID (30 minutes after breakfast/dinner) 12 weeks

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Institute of Medicinal Molecular Design, Inc.: lead

Study Sites (2)

King Edward VII Hospital (Imperial College, London)

Windsor, Berkshire, SL4 3DP, United Kingdom

Location

Medicines Evaluation Unit, Wythenshawe Hospital

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

IMD-1041

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Ford, MB, BS, MRCP, PhD

  King Edward VII Hospital, Windsor, Berkshire, SL4 3DP, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 17, 2009
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 23, 2009

Record last verified: 2009-04

Locations

GB (2)