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A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582503
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.

Condition or disease Intervention/treatment Phase
Asthma Drug: MEMP1972A Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of MEMP1972A in Adults With Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA)
Study Start Date : April 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: MEMP1972A 150 mg Drug: MEMP1972A
Subcutaneous repeating dose

Experimental: MEMP1972A 300 mg Drug: MEMP1972A
Subcutaneous repeating dose

Experimental: MEMP1972A 450 mg Drug: MEMP1972A
Subcutaneous repeating dose

Placebo Comparator: Placebo Drug: placebo
Subcutaneous repeating dose

Primary Outcome Measures :
  1. Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36 [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. Relative change in pre-bronchodilator FEV1 (volume) [ Time Frame: from baseline to Week 12 ]
  2. Relative change in FEV1 (volume) [ Time Frame: from baseline to Week 36 ]
  3. Change in asthma symptoms [ Time Frame: from baseline to Week 12 ]
  4. Change in asthma symptoms [ Time Frame: from baseline to Week 36 ]
  5. Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36 [ Time Frame: 12 weeks ]
  6. Safety: Incidence of adverse events [ Time Frame: 48 weeks ]
  7. Incidence of anti-therapeutic antibodies (ATAs) [ Time Frame: 84 weeks ]
  8. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, 18 to 75 years of age inclusive
  • Body weight >/= 40 kg
  • Physician's diagnosis of asthma for at least 12 months
  • Evidence of documented bronchodilator reversibility as defined by protocol
  • Prebronchodilator FEV1 >/= 40% and </= 80% predicted at Visit 1
  • Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
  • History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
  • Inadequately controlled asthma despite compliance with asthma controller therapy

Exclusion Criteria:

  • Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
  • Pre-existing active lung disease other than asthma
  • Any infection
  • Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
  • Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
  • Current substance abuse
  • Former smoker with >10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
  • History of anaphylaxis
  • Pregnant and lactating women

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 identifier (NCT number): NCT01582503

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Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Genentech, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Genentech, Inc. Identifier: NCT01582503    
Other Study ID Numbers: GB27980
2011-003997-10 ( EudraCT Number )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases