NCT00940927

Brief Summary

The purpose of this study was to determine the lung function response after increasing doses of albuterol (a bronchodilator) in children and adults with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jul 1993

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1993

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1994

Completed
13.7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

July 17, 2009

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

June 27, 2008

Results QC Date

February 3, 2009

Last Update Submit

April 14, 2015

Conditions

Asthma

Keywords

AlbuterolForced expiratory volume in one secondDose at fifty percent of maximum effectMaximum effective doseMetered dose inhalerNebulizer

Outcome Measures

Primary Outcomes (2)

  • Effective Dose 50% (ED50)

    ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol

    15 minutes after each dose

  • Effect Maximum (Emax)

    Maximum percentage of predicted FEV1 effect

    15 minutes after each dose

Interventions

albuterolDRUG

Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)

Also known as: Proventil MDI, Proventil solution for nebulization

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligibility Criteria: * Well-defined history of physician diagnosed asthma * Any ethnic background * 8 to 65 years old * Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender * No oral corticosteroid use, emergency room visits, or hospitalizations within the previous 3 months * Nonsmokers or less than a 5 pack-year history with no smoking in the previous year * Normal physical exam and no confounding diseases were selected * Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for 8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn, nedocromil, and inhaled corticosteroids for 2 hours prior to the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Related Publications (1)

  • Blake K, Madabushi R, Derendorf H, Lima J. Population pharmacodynamic model of bronchodilator response to inhaled albuterol in children and adults with asthma. Chest. 2008 Nov;134(5):981-989. doi: 10.1378/chest.07-2991. Epub 2008 Jun 26.

    PMID: 18583517RESULT

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Results Point of Contact

Title
Kathryn Blake, Pharm.D.
Organization
Nemours Children's Clinic
kblake@nemours.org
904 858 3806

Study Officials

  • Kathryn V Blake, Pharm.D.

    Nemours Children's Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 17, 2009

Study Start

July 1, 1993

Primary Completion

October 1, 1994

Study Completion

October 1, 1994

Last Updated

May 5, 2015

Results First Posted

July 17, 2009

Record last verified: 2015-04

Locations

US(1)