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)

Institute of Medicinal Molecular Design, Inc.0 sites50 target enrollmentApril 25, 2008

ConditionsChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Institute of Medicinal Molecular Design, Inc.
Enrollment: 50
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 25, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Institute of Medicinal Molecular Design, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Males and non\-pregnant, non\-lactating females aged \=40 and \=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\)
•2\. Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction
•3\. 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)
•4\. Post\-salbutamol FEV1/forced vital capacity (FVC) \<70% (i.e,. 100 x post\-salbutamol FEV1/FVC \<70%) (at either screening or baseline)
•5\. Current, or ex\-cigarette smokers with a smoking history of at least 10 pack\-years. Pack\-years will be calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person had smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack\-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack \= 2; 2 x 10 years of smoking \= 20 pack\-year history)
•6\. Patients who have the ability to produce a viable sputum sample (\< 50% squamous cells)
•7\. Predominant current diagnosis of smoking related COPD
•8\. 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\. 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
•2\. Eosinophil count \>600 cells/mm3
•3\. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit
•4\. 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
•5\. Use of long\-term oxygen therapy (\=15 hours/day)
•6\. 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