Text Size

Dose-response of Albuterol in Asthmatics

This study has been completed.
Sponsor:
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00940927
First received: June 27, 2008
Last updated: July 23, 2009
Last verified: July 2009
History of Changes
Results First Received: February 3, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: albuterol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from our asthma research clinic database or newspaper advertisements. Participants were recruited from 07/1993 to 10/1994.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Albuterol Increasing doses of albuterol by MDI and nebulizer solution

Participant Flow:   Overall Study
    Albuterol  
STARTED     81  
COMPLETED     81  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Albuterol Increasing doses of albuterol by MDI and nebulizer solution

Baseline Measures
    Albuterol  
Number of Participants  
[units: participants]
 		  81  
Age  
[units: participants]
 		 
<=18 years     31  
Between 18 and 65 years     48  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  30.2  ± 17.4  
Gender  
[units: participants]
 		 
Female     45  
Male     36  
Region of Enrollment  
[units: participants]
 		 
United States     81  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effective Dose 50% (ED50)   [ Time Frame: 15 minutes after each dose ]
  Show Outcome Measure 1

2.  Primary:   Effect Maximum (Emax)   [ Time Frame: 15 minutes after each dose ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events
No Other Adverse Events Entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Kathryn Blake, Pharm.D.
Organization: Nemours Children's Clinic
phone: 904 858 3806
e-mail: kblake@nemours.org


Publications of Results:


Responsible Party: Kathryn Blake, Pharm.D., Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00940927     History of Changes
Other Study ID Numbers: 93-41
Study First Received: June 27, 2008
Results First Received: February 3, 2009
Last Updated: July 23, 2009
Health Authority: United States: Institutional Review Board