Completed

DREAMA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Mepolizumab 750

+ Mepolizumab 250

+ Mepolizumab 75

BiologicalDrug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

From 12 to 65 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: November 2009
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Determine the Effect of Mepolizumab on Exacerbation Rates in Subjects With Severe Uncontrolled Refractory Asthma
NCT01000506
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

621 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 12 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

15 inclusion criteria required to participate
Minimum weight 45kg
Male or female
Aged 12 to 65 years inclusive
Clinical features of severe refractory asthma
Show More Criteria
18 exclusion criteria prevent from participating
Current smokers or smoking history of >=10 pack years
Clinically important lung condition other than asthma
Diagnosis of malignancy or in the process of investigation
Unstable liver disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Mepolizumab 750mcg i.v. every 4 weeks

Group II

Active Comparator
Mepolizumab 250mcg i.v. every 4 weeks

Group III

Active Comparator
Mepolizumab 75mcg i.v. every 4 weeks

Group IV

Placebo
Placebo saline every 4 weeks i.v.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 94 locations

Suspended

GSK Investigational Site

Long Beach, United StatesOpen GSK Investigational Site in Google Maps
Suspended

GSK Investigational Site

Los Angeles, United States
Suspended

GSK Investigational Site

Riverside, United States
Suspended

GSK Investigational Site

San Diego, United States
Completed94 Study Centers