Clinical trial NCT00967590: A Study of RO5036505 in Patients With Moderate to Severe Asthma
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ACQ questionnaire, spirometry assessments, PEFR
timeFrame: every week up to day 95
measure: Safety and tolerability: AEs, spirometry, concomitant medications, laboratory parameters
timeFrame: assessed every week, laboratory parameters every 3-4 weeks, up to day 95
Secondary outcomes:
measure: Pharmacokinetics: AUC, Cmax, t1/2, V steady-state, clearance
timeFrame: sampling every week up to day 95
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Normal
country: United States
state: Illinois
city: River Forest
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Spartanburg
country: United States
state: South Carolina
city: Galveston
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
city: Hereford
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: