Chronic Obstructive Pulmonary Disease Clinical Trial
— SPRINGOfficial title:
A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
| Verified date | March 2014 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
| Status | Completed |
| Enrollment | 464 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Age 45 through 75 years. - Predicted (GOLD stage II, III, and IV) at screening. - History of previous AECOPD 12 months prior to screening Clinically stable and free from an AECOPD for 8 weeks prior to Day 1. - Current smoker or ex-smoker with a tobacco history of = 10 pack-years Exclusion Criteria: - Past or present disease or disorder, - Significant or unstable ischemic heart disease, etc - Known history of allergy or reaction to any component of the IMP - Past or current malignancy within the past 5 years - Subjects have had a chest x-ray or CT scan suggestive of malignancy or tuberculosis (TB). - Use of immunosuppressive medication receipt of any biologic agent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Ruse | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Stara Zagora | |
| Bulgaria | Research Site | Veliko Tarnovo | |
| Czech Republic | Research Site | Brno | |
| Czech Republic | Research Site | Jindrichuv Hradec | |
| Czech Republic | Research Site | Karlovy Vary | |
| Czech Republic | Research Site | Plzen | |
| Czech Republic | Research Site | Praha 10 | |
| Czech Republic | Research Site | Strakonice | |
| Hungary | Research Site | Balassagyarmat | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Farkasgyepü | |
| Hungary | Research Site | Komarom | |
| Hungary | Research Site | Mateszalka | |
| Hungary | Research Site | Matrahaza | |
| Hungary | Research Site | Mosonmagyarovar | |
| Hungary | Research Site | Nagykanizsa | |
| Hungary | Research Site | Szikszo | |
| Hungary | Research Site | Tatabanya | |
| Hungary | Research Site | Torokbalint | |
| Latvia | Research Site | Daugavpils | |
| Latvia | Research Site | Riga | |
| Lithuania | Research Site | Kaunas | |
| Lithuania | Research Site | Klaipeda | |
| Lithuania | Research Site | Vilnius | |
| Philippines | Research Site | Iloilo City | |
| Philippines | Research Site | Lipa City | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Oswiecim | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Zgierz | |
| Ukraine | Research Site | Ivano-Frankivsk | |
| Ukraine | Research Site | Kharkiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Odessa | |
| Ukraine | Research Site | Poltava | |
| Ukraine | Research Site | Simferopol | |
| Ukraine | Research Site | Vinnytsya | |
| United Kingdom | Research Site | Cambridge | |
| United Kingdom | Research Site | Newcastle upon Tyne | |
| United Kingdom | Research Site | Wolverhampton | |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Boerne | Texas |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Duluth | Georgia |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Peoria | Arizona |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Spartanburg | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
United States, Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Philippines, Poland, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the effect of MEDI8968 on the rate of acute exacerbations of COPD (AECOPD) in adult subjects with COPD; GOLD II-IV on standard maintenance therapy | Approximately 12 months | Yes |
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