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CompletedNCT00268723Updated Feb 22, 2012

Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB

A Phase 3 interventional study of Levalbuterol tartrate HFA MDI and Placebo in Exercise-induced Bronchospasm, sponsored by Sumitomo Pharma America, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Sumitomo Pharma America, Inc. (part of Sumitomo Pharma Co., Ltd.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

02

Conditions studied

  • Exercise-induced Bronchospasm
03

In context

Asthma, Exercise-Induced

52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

This study's enrollment of 15 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 181 studies on the registry; 5 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 21 (64%) have results posted.

First submitted before Sumitomo Pharma America, Inc. became part of Sumitomo Pharma Co., Ltd..

Browse Sumitomo Pharma America, Inc. studies →All Sumitomo Pharma Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects were males or females and 18 years of age or older at the time of consent.
  • Female subjects considered not of were either surgically sterile or greater than one-year , defined as a complete cessation of menstruation for at least one year.
  • Female subjects of child-bearing potential had a negative urine pregnancy test at screening.
  • Female subjects of child-bearing potential agreed to use an acceptable method of throughout the study.
  • Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias).
  • Subjects had a documented diagnosis of exercise-induced bronchospasm for a minimum of 6 months prior to study start.
  • Subjects had stable baseline asthma and had been using a beta2-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to study start.

Exclusion criteria

Exclusion Criteria

  • Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
  • Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial.
  • Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
  • Subjects who suffered from a upper or lower respiratory tract infection in the 3 weeks prior to study start.
  • Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol.
  • Subjects with a history of cancer (exception: basal-cell carcinoma in remission for a minimum of 5 years).
  • Subjects with a known sensitivity to levalbuterol, racemic albuterol, or any of the contained in any of these formulations.
  • Subjects using any prescription drug with which levalbuterol tartrate administration is .
  • Subjects with a history of substance abuse or drug abuse within 12 months preceding study start.
  • Subjects who participated in an drug study within 30 days prior to study start, or who were currently participating in another clinical trial.
  • Subjects with a greater than 10-pack-year history of cigarette smoking or use of any tobacco products within 6 months of study start.
  • Subject was a staff member or relative of a staff member.
  • Subjects with unstable asthma, or had a change in asthma therapy, or a visit to the emergency department or hospital for worsening asthma within 4 weeks of study start.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    levalbuterol HFA MDI 90 mcg QID

    Drug: Levalbuterol tartrate HFA MDI

  • Placebo comparator
    2

    Placebo MDI QID

    Drug: Placebo

Interventions

  • DrugLevalbuterol tartrate HFA MDI

    levalbuterol MDI 90 mcg QID

    Also known as: Xopenex MDI

  • DrugPlacebo

    Placebo MDI QID

06

What researchers measure

Primary outcomes

  1. maximum percent FEV1 decrease from visit postdose/prechallenge

    Time frame: Days 1, 4, 7

Secondary outcomes

  1. FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)

    Time frame: Days 1, 4, 7

  2. time to FEV1 recovery

    Time frame: Days 1, 4, 7

  3. minimum percent change in FEV1 from visit postdose/prechallenge

    Time frame: Days 1, 4, 7

  4. minimum percent change in FEV1 from visit predose

    Time frame: Days 1, 4, 7

  5. protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)

    Time frame: Days 1, 4, 7

  6. percent change in FEV1 from predose to postdose/prechallenge

    Time frame: Days 1, 4, 7

07

Study locations

2 sites
  • Denver, Colorado, United States
  • Burke, Virginia, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2005, a primary completion of Feb 2006 and a completion of Feb 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2005
First posted
Dec 22, 2005
Start
Dec 2005
Primary completionActual
Feb 2006
CompletionActual
Feb 2006
Last update
Feb 22, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00268723
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Dec 22, 2005
Start date
Dec 2005
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Feb 22, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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