A Study to Evaluate the Dosing of AMG 827 for Subjects With Inadequately Controlled Asthma
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT01199289
First received: August 5, 2010
Last updated: September 22, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: AMG 827 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects With Inadequately Controlled Asthma |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- The primary objective is to determine if AMG 827 is effective compared to placebo as mesasured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the efficacy of AMG 827 as measured by Pre- and post-bronchodilator FEV1 (forced expiratory volume in 1 second) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of AMG 827 as measured by am and pm Peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of AMG 827 as measured by use of rescue Short Acting β-Agonist (SABA) use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of AMG 827 as measured by daily asthma symptoms (aggregate/night and individual) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Evaluate the efficacy of AMG 827 as measured by Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 315 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AMG 827 280 mg
280 mg AMG 827
|
Drug: AMG 827
280 mg AMG 827 SC
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo SC
|
|
Experimental: AMG 827 140 mg
140 mg AMG 827
|
Drug: AMG 827
140 mg AMG 827 SC
|
|
Experimental: AMG 827 210 mg
210 mg AMG 827
|
Drug: AMG 827
210 mg AMG 827 SC
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men or women 18 to 65 years of age
- Percent of predicted FEV1 ≥ 50% and ≤ 80%
- At least 12% reversibility over pre-bronchodilator FEV1
- Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000 µg/day fluticasone or equivalent.
- Ongoing asthma symptoms with ACQ composite score ≥ 1.5 points
Exclusion Criteria:
- Respiratory infection within 4 weeks of screening visit or 1 week of baseline visit
- History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
- Any uncontrolled or clinically significant systemic disease (eg, uncontrolled diabetes, liver disease)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199289
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Research Site | |
| Encinitas, California, United States | |
| Research Site | |
| Huntington Beach, California, United States | |
| Research Site | |
| Los Angeles, California, United States | |
| Research Site | |
| San Diego, California, United States | |
| Research Site | |
| Stockton, California, United States | |
| United States, Colorado | |
| Research Site | |
| Colorado Springs, Colorado, United States | |
| United States, Georgia | |
| Research Site | |
| Stockbridge, Georgia, United States | |
| United States, Maryland | |
| Research Site | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Research Site | |
| North Dartmouth, Massachusetts, United States | |
| United States, Missouri | |
| Research Site | |
| St Louis, Missouri, United States | |
| United States, Montana | |
| Research Site | |
| Bozeman, Montana, United States | |
| United States, Nebraska | |
| Research Site | |
| Bellevue, Nebraska, United States | |
| United States, New Jersey | |
| Research Site | |
| Skillman, New Jersey, United States | |
| United States, New York | |
| Research Site | |
| Rockville Centre, New York, United States | |
| United States, North Carolina | |
| Research Site | |
| High Point, North Carolina, United States | |
| United States, Ohio | |
| Research Site | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Research Site | |
| Lake Oswego, Oregon, United States | |
| Research Site | |
| Medford, Oregon, United States | |
| United States, Pennsylvania | |
| Research Site | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Research Site | |
| Dallas, Texas, United States | |
| Research Site | |
| El Paso, Texas, United States | |
| United States, Wisconsin | |
| Research Site | |
| Madison, Wisconsin, United States | |
| Austria | |
| Research Site | |
| Feldbach, Austria | |
| Research Site | |
| Hallein, Austria | |
| Research Site | |
| Wien, Austria | |
| Belgium | |
| Research Site | |
| Bruxelles, Belgium | |
| Research Site | |
| Leuven, Belgium | |
| Research Site | |
| Liege, Belgium | |
| Canada, Alberta | |
| Research Site | |
| Calgary, Alberta, Canada | |
| Canada, Ontario | |
| Research Site | |
| Ottawa, Ontario, Canada | |
| Research Site | |
| Toronto, Ontario, Canada | |
| Finland | |
| Research Site | |
| Helsinki, Finland | |
| Research Site | |
| Jyväskylä, Finland | |
| Research Site | |
| Turku, Finland | |
| Hungary | |
| Research Site | |
| Edeleny, Hungary | |
| Research Site | |
| Matrahaza, Hungary | |
| Research Site | |
| Tatabanya, Hungary | |
| Research Site | |
| Torokbalint, Hungary | |
| Research Site | |
| Zalaegerszeg - Pozva, Hungary | |
| Korea, Republic of | |
| Research Site | |
| Bucheon-si, Korea, Republic of | |
| Research Site | |
| Seoul, Korea, Republic of | |
| Research Site | |
| Suwon, Korea, Republic of | |
| Netherlands | |
| Research Site | |
| Rotterdam, Netherlands | |
| Poland | |
| Research Site | |
| Bialystok, Poland | |
| Research Site | |
| Chodziez, Poland | |
| Research Site | |
| Gdansk, Poland | |
| Research Site | |
| Wroclaw, Poland | |
| Russian Federation | |
| Research Site | |
| Moscow, Russian Federation | |
| Research Site | |
| Saint Petersburg, Russian Federation | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT01199289 History of Changes |
| Other Study ID Numbers: | 20090203 |
| Study First Received: | August 5, 2010 |
| Last Updated: | September 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Amgen chronic inflammatory disease wheezing |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013