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AsthmaPhase 3NCT00073840

Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

A Phase 3 study testing levalbuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
levalbuterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
386 participants
Where
54 sitesUnited States
Study dates
Dec 2002to Jun 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum
  • Be willing and able to comply with the study procedures and visit schedules
  • Male or female, at least 12 years of age
  • Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)
  • Women of child bearing potential must be using an acceptable method of birth control
  • Must have a documented diagnosis of asthma for a min. of 6 mos. prior to V1
Show all 12Show fewer
  • At V1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted for their height, age, gender, and race
  • Following abstention from medications used to treat asthma, subject must demonstrate >12% reversibility of airflow obstruction within 15-30 min. following inhalation of 180 µg (2 actuations, 90 µg ea.) of racemic albuterol MDI
  • Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 mos. prior to V1
  • Must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
  • Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
  • Must be able to complete the diary cards and medical event calendars reliably on a daily basis and demonstrate how to use the MiniWright PEF meter

Who cannot join

  • Subject who is expected to require any disallowed medications
  • Female subject who is pregnant or lactating
  • Subject who has participated in an investigational drug study within 30 days prior to V1, or who is currently participating in another clinical trial
  • Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9AM
  • Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both
  • Subject who has a history of hospitalization for asthma within 45 days prior to V1, or who is scheduled for in-patient hospitalization during the trial
Show all 19Show fewer
  • Have a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
  • Subject using any prescription drug with which albuterol sulfate administration is contraindicated
  • Subject with currently diagnosed life-threatening asthma
  • Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
  • Have a history of cancer (exception: basal cell carcinoma in remission)
  • Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders not well controlled by medication or that may interfere with the successful completion of this protocol
  • Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive urine drug screening at V1
  • Have greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 mos. of V1
  • Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
  • Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to V1
  • Have any clinically significant abnormal laboratory values
  • Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete study
  • Subject who is a staff member or relative of a staff member

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Allergy and Asthma Clinic of Central Texas

    Austin, Texas, 78749

  • Watts Medical Research

    Barnesville, Georgia, 30204

  • Pulmonary Medical Research of NY, PLLC

    Bay Shore, New York, 11706

  • PI - Coor Clinical Research, LLC

    Burke, Virginia, 22015

  • Charlotte Lung and Health Center

    Charlotte, North Carolina, 28207

  • Rush Presbyterian - St. Luke's Medical Center Rush University

    Chicago, Illinois, 60612

  • New Horizons Clinical Research, Inc.

    Cincinnati, Ohio, 45241

  • The Allergy & Asthma Clinical Research Center

    Conyers, Georgia, 30013

  • Integrated Research Group

    Corona, California, 92879

  • Asthma & Allergy Associates PC

    Cortland, New York, 13046

  • Research Across America

    Dallas, Texas, 75234

  • Valley Clinical Research Center

    Easton, Pennsylvania, 18045

  • Albermarle Allergy & Asthma PC

    Elizabeth City, North Carolina, 27909

  • Radiant Research, Inc.

    Encinitas, California, 92024

  • Allergy, Asthma and Sinus Center F.C.

    Greenfield, Wisconsin, 53228

  • Allergic Disease & Asthma Center PA

    Greenville, South Carolina, 29607

  • Breco Research

    Houston, Texas, 77024

  • Breath of Life Research Institute

    Houston, Texas, 77084

  • Allergy & Asthma Specialists Medical Group

    Huntington Beach, California, 92647

  • Office of Yekaterina Khronusova, MD

    Las Vegas, Nevada, 89119

  • Asthma, Allergy & Respiratory Care Center

    Long Beach, California, 90808

  • Allergy Research Foundation, Inc.

    Los Angeles, California, 90025

  • Madera Family Medical Group

    Madera, California, 93637

  • Clinical Research Specialist

    Metairie, Louisiana, 70006

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Southern California Research

    Mission Viejo, California, 92691

  • Allergy & Asthma Consultants, LLP

    Mt. Pleasant, South Carolina, 29464

  • Doctor's Care

    New Orleans, Louisiana, 70122

  • Comprehensive Allergy Services

    Oakland, California, 94609

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Heartland Clinical Research Inc.

    Omaha, Nebraska, 68134

  • Clinical Trials of Orange County

    Orange, California, 92868

  • Allergy & Asthma Center, LLC

    Oxford, Alabama, 36203

  • Asthma & Allergy Center PC

    Papillion, Nebraska, 68046

  • Allergy Associates Research Center, LLC

    Portland, Oregon, 97213

  • Pulmonary Associates of Richmond, inc.

    Richmond, Virginia, 23225

  • AAIR Research Center

    Rochester, New York, 14618

  • Lung Diagnostics

    San Antonio, Texas, 78229

  • Allergy Associates Medical Group

    San Diego, California, 92120

  • Allergy & Asthma Medical Group & Research Center

    San Diego, California, 92123

  • Allergy & Asthma Assoc. of Santa Clara Valley Research Center

    San Jose, California, 95117

  • Aeroallergy Research Laboratories of Savannah, Inc.

    Savannah, Georgia, 31406

  • West Coast Clinical Trials

    Signal Hill, California, 90755

  • Children's International Medical Research

    Slidell, Louisiana, 70458

  • South Bend Clniic

    South Bend, Indiana, 46617

  • Rockwood Clinics, PS

    Spokane, Washington, 99220

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Advanced Clinical Concepts

    Temple, Pennsylvania, 19560

  • 1st Allergy & Asthma Clinical Research Ctr

    Thornton, Colorado, 80233

  • Office or Richard Castaldo, MD

    Tonawanda, New York, 14150

  • Alta Clinical Research

    Tucson, Arizona, 85745

  • Allergy & Asthma Medical Group of Diablo Valley, Inc.

    Walnut Creek, California, 94598

  • Allergic Diseases, SC

    West Allis, Wisconsin, 53227

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Read the detailed description

A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. 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.

Conditions
Asthma
Being tested
levalbuterol
Keywords
levalbuterol, asthma, bronchoconstriction, adolescent, adult
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levalbuterolDrug

    Also called Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol

    • Levalbuterol 90 ųg QID (manufacturing sites A or B);
    • Racemic Albuterol 180 ųg QID;
    • Placebo QID
Study groups in NCT00073840
Study groupRoleWhat they receive
IActive comparatorLevalbuterol 90 ųg QID (manufacturing site A or B)
Receives: Drug: levalbuterol
IIActive comparatorRacemic Albuterol 180 ųg QID
Receives: Drug: levalbuterol
IIIPlacebo comparatorPlacebo QID
Receives: Drug: levalbuterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1 (peak percent change from pre-dose averaged over the double-blind period).

    Measured: 8 weeks

Secondary outcomes (1)

  1. --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2003 (estimated)
  2. Study startDec 2002
  3. Primary completionJun 2003
  4. Study completionJun 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073840
Sponsor's protocol ID
051-355
Status last verified
Feb 2012
First submitted
9 Dec 2003
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.

    PubMed 20851928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levalbuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (peak percent change from pre-dose averaged over the double-blind period). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00073840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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