Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay

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. Identifier: NCT00643578
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : November 18, 2011
Last Update Posted : December 5, 2011
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Asthma
Interventions: Drug: formoterol
Device: Dry Powder Inhaler (Twisthaler)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April and November, 2008, the UF Asthma Research Lab recruited 37 patients for study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 37 subjects who signed informed consent, 25 did not meet inclusion/exclusion criteria. The provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second (PC20FEV1) was not less than or equal to 4 mg/mL.

Reporting Groups
Formoterol 12 First a single dose of 12 mcg of formoterol was given first, then 24 mcg of formoterol
Formoterol 24 First a single dose of 24 mcg of formoterol was given first, then 12 mcg of formoterol

Participant Flow:   Overall Study
    Formoterol 12 First   Formoterol 24 First
STARTED   6   6 
COMPLETED   4   6 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
All Participants A single dose of 12 mcg and 24 mcg, on separate days, of formoterol were given.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 36.8  (14.5) 
[Units: Participants]
Female   7 
Male   5 
Region of Enrollment 
[Units: Participants]
United States   12 

  Outcome Measures

1.  Primary:   Post-dose PC20   [ Time Frame: 3-7 days after visits 1 and 2 ]

2.  Secondary:   FEV1   [ Time Frame: 1 hour after dose ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Leslie Hendeles
Organization: University of Florida Asthma Research Lab
phone: 352-273-6027


Responsible Party: University of Florida Identifier: NCT00643578     History of Changes
Other Study ID Numbers: Ivax-65307
First Submitted: March 20, 2008
First Posted: March 26, 2008
Results First Submitted: August 5, 2011
Results First Posted: November 18, 2011
Last Update Posted: December 5, 2011