A Study of RO5036505 in Patients With Moderate to Severe Asthma

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: NCT00967590
Recruitment Status : Withdrawn (No patients dosed)
First Posted : August 28, 2009
Last Update Posted : August 24, 2016
Information provided by:
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma. Patients will be randomized to receive either RO5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. Patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. Target sample size is 50-100 individuals.

Condition or disease Intervention/treatment Phase
Asthma Drug: RO5036505 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-Blind, Multiple-Dose, Placebo-controlled Asthma Control Study Evaluating the Efficacy, Safety, and Tolerability of RO5036505 in Subjects With Moderate-to-Severe Asthma
Study Start Date : September 2009
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1 Drug: RO5036505
380mg iv infusion once weekly for 8 weeks

Placebo Comparator: 2 Drug: placebo
iv infusion once weekly for 8 weeks

Primary Outcome Measures :
  1. ACQ questionnaire, spirometry assessments, PEFR [ Time Frame: every week up to day 95 ]
  2. Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters [ Time Frame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95 ]

Secondary Outcome Measures :
  1. Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance [ Time Frame: sampling every week up to day 95 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-70 years of age
  • moderate to severe asthma for >/=2 years
  • ACQ score >/= 1.5
  • ICS and LABA regimen at moderate to high dose
  • non-smokers

Exclusion Criteria:

  • oral corticosteroid use within 4 weeks prior to screening
  • current escalating immunotherapy
  • acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection
  • pulmonary disease other than asthma
  • therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening
  • previous exposure to investigational monoclonal antibodies or biologics

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): NCT00967590

United States, Arkansas
Little Rock, Arkansas, United States, 72202
United States, California
San Diego, California, United States, 92103
United States, Colorado
Denver, Colorado, United States, 80206
United States, Illinois
Normal, Illinois, United States, 61761
River Forest, Illinois, United States, 60305
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Saint Louis, Missouri, United States, 63130
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Galveston, Texas, United States, 77555-0561
United States, Wisconsin
Madison, Wisconsin, United States, 53792
United Kingdom
Hereford, United Kingdom, HR1 2ER
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00967590     History of Changes
Other Study ID Numbers: PP22666
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016

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