Phase 3 Asthma Trial, Completed NCT01691521 Sponsor: GlaxoSmithKline Condition: Asthma
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 576 adults across three groups: 191 received a placebo (dummy treatment), 191 received mepolizumab given into a vein (75 mg IV), and 194 received mepolizumab given by injection under the skin (100 mg SC). The trial ran for 32 weeks and was primarily measuring how often participants had serious asthma flare-ups — defined as episodes bad enough to need steroid medicines, a hospital stay, or an emergency department visit. The reported data shows that for the main outcome, the placebo group had a reported rate of 1.74 serious flare-ups per year, compared to 0.93 per year in the IV mepolizumab group and 0.83 per year in the under-the-skin mepolizumab group. For flare-ups that led to a hospital stay or emergency department visit, the reported rates were 0.20 (placebo), 0.14 (IV), and 0.08 (under-the-skin) per year. For flare-ups requiring hospitalisation alone, the reported figures were 0.10, 0.06, and 0.03 per year respectively. The reported data also shows that lung function (measured as the amount of air expelled in one second) changed from the starting point by an average of 86 millilitres in the placebo group, 186 mL in the IV group, and 183 mL in the under-the-skin group. Finally, a quality-of-life questionnaire (scored 0–100, where higher scores mean greater impact on daily life) showed average score changes of −9.0 (placebo), −15.4 (IV), and −16.0 (under-the-skin) from the start of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Asthma Trial, Completed

NCT01691521
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are able to read, understand, and sign a consent form before the study begins
  • You are at least 12 years old and weigh at least 45 kg (about 99 lbs)
  • You have been regularly taking high-dose asthma preventer inhalers (steroid-based) for the past 12 months, with or without steroid tablets
  • You have been taking at least one other asthma controller medication for 3 or more months, or you tried one in the past 12 months and it did not work well enough
  • You have been diagnosed with, or are very likely to have, a type of asthma linked to high levels of a certain white blood cell called eosinophils
  • Your lung function test results fall below a certain level (confirm with trial site for exact numbers based on your age)
  • You have had two or more serious asthma attacks in the past that needed steroid treatment
  • You are male, or a female who either cannot become pregnant or is willing to use reliable contraception throughout the study
  • If you are based in France, you must be part of the French social security system

Who may not be able to join:

  • You currently smoke, or you are a former smoker who smoked heavily for 10 or more years
  • You have a significant lung condition other than asthma
  • You currently have cancer, or have had cancer within the past 12 months
  • You have unstable liver disease, cirrhosis, or known problems with your bile ducts
  • You have a serious or unstable heart or cardiovascular condition
  • You have another significant ongoing health condition that is not well controlled with standard treatment
  • You have another medical condition involving high eosinophil levels (a type of white blood cell)
  • Your heart's electrical activity (measured by an ECG) shows certain abnormal readings (confirm with trial site)
  • You have a history of alcohol or drug misuse
  • You have a known problem with your immune system
  • You have received a specific asthma injection treatment called omalizumab (Xolair) within about 4 months before the study, or certain other similar biological treatments recently
  • You have taken part in a study involving an experimental drug within the past 30 days (or longer, depending on the drug)
  • You have an allergy or intolerance to antibody-based or biological treatments
  • You are currently pregnant or breastfeeding
  • You have a known history of not following prescribed medication routines or medical advice
  • You have previously taken part in a study involving the drug mepolizumab and actually received it (including a dummy/placebo version)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: GSK Clinical Trials, GlaxoSmithKline

Australian sites

GSK Investigational Site, New Lambton, New South Wales
GSK Investigational Site, Bedford Park, South Australia
GSK Investigational Site, Clayton, Victoria
GSK Investigational Site, Nedlands, Western Australia
GSK Investigational Site, Parkville,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
8 October 2012
Est. completion
1 January 2014

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Clinically Significant Exacerbations of Asthma Per Year

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov