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AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma

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ClinicalTrials.gov Identifier: NCT01018550
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12.

Condition or disease Intervention/treatment Phase
Asthma Drug: AMG 853 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects With Inadequately Controlled Asthma
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AMG 853 Drug: AMG 853
AMG 853 5 mg (BID)
Drug: AMG 853
AMG 853 200 mg (QD)
Drug: AMG 853
AMG 853 25 mg (BID)
Drug: AMG 853
AMG 853 100 mg (BID)
Placebo Comparator: Placebo Drug: Placebo
Placebo



Primary Outcome Measures :
  1. The primary objective is to determine if AMG 853 is effective compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from baseline to week 12. [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Evaluate the efficacy of AMG 853 as measured by use of rescue short-acting β-agonist (SABA) [ Time Frame: Baseline to Week 12 ]
  2. Evaluate the efficacy of AMG 853 as measured by daily symptom score (aggregate/night and individual symptoms; and symptom free days) [ Time Frame: Baseline to Week 12 ]
  3. Evaluate the efficacy of AMG 853 as measured by pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline to Week 12 ]
  4. Evaluate the efficacy of AMG 853 as measured by AM and PM peak expiratory flow rate (PEFR) [ Time Frame: Baseline to Week 12 ]
  5. Evaluate the efficacy of AMG 853 as measured by asthma quality of life questionnaire (AQLQ) [ Time Frame: Baseline to Week 12 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females 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 score ≥ 1.5 points

Exclusion Criteria:

  • History of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
  • Any uncontrolled, clinically significant systemic disease
  • Respiratory infection within 4 weeks of the screening visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018550


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01018550     History of Changes
Other Study ID Numbers: 20080615
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases