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Trial record 57 of 857 for:    ALBUTEROL

Dose-response of Albuterol in Asthmatics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00940927
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : July 17, 2009
Last Update Posted : May 5, 2015
Sponsor:
Information provided by:
Nemours Children's Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: albuterol
Enrollment 81
Recruitment Details Participants were recruited from our asthma research clinic database or newspaper advertisements. Participants were recruited from 07/1993 to 10/1994.
Pre-assignment Details Participants had to withhold inhaled short-acting beta2 agonist or inhaled anticholinergic drugs for 8 h, oral antihistamines for 5 days, theophylline for 24 h, and cromolyn, nedocromil, and inhaled corticosteroids for 2 h prior to the study.
Arm/Group Title Albuterol
Hide Arm/Group Description Increasing doses of albuterol by MDI and nebulizer solution
Period Title: Overall Study
Started 81
Completed 81
Not Completed 0
Arm/Group Title Albuterol
Hide Arm/Group Description Increasing doses of albuterol by MDI and nebulizer solution
Overall Number of Baseline Participants 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
<=18 years
31
  38.3%
Between 18 and 65 years
48
  59.3%
>=65 years
2
   2.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants
30.2  (17.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants
Female
45
  55.6%
Male
36
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants
81
1.Primary Outcome
Title Effective Dose 50% (ED50)
Hide Description ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol
Time Frame 15 minutes after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol
Hide Arm/Group Description:
Increasing doses of albuterol by MDI and nebulizer solution
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: ug
141
2.Primary Outcome
Title Effect Maximum (Emax)
Hide Description Maximum percentage of predicted FEV1 effect
Time Frame 15 minutes after each dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol
Hide Arm/Group Description:
Increasing doses of albuterol by MDI and nebulizer solution
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: percentage of predicted
24.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol
Hide Arm/Group Description Increasing doses of albuterol by MDI and nebulizer solution
All-Cause Mortality
Albuterol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol
Affected / at Risk (%)
Total   0/81 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol
Affected / at Risk (%)
Total   0/81 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn Blake, Pharm.D.
Organization: Nemours Children's Clinic
Phone: 904 858 3806
EMail: kblake@nemours.org
Layout table for additonal information
Responsible Party: Kathryn Blake, Pharm.D., Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00940927     History of Changes
Other Study ID Numbers: 93-41
First Submitted: June 27, 2008
First Posted: July 17, 2009
Results First Submitted: February 3, 2009
Results First Posted: July 17, 2009
Last Update Posted: May 5, 2015