Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00643578
First received: March 20, 2008
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Asthma
Interventions: Drug: formoterol
Device: Dry Powder Inhaler (Twisthaler)

  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
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
  Description
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  
NOT COMPLETED     2     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  12  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  36.8  ± 14.5  
Gender  
[units: participants]
 		 
Female     7  
Male     5  
Region of Enrollment  
[units: participants]
 		 
United States     12  



  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Post-dose PC20
Measure Description The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.
Time Frame 3-7 days after visits 1 and 2  
Safety Issue No  

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.
Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.

Reporting Groups
  Description
12 Mcg Formoterol low dose
24 Mcg Formoterol high dose

Measured Values
    12 Mcg Formoterol     24 Mcg Formoterol  
Number of Participants Analyzed  
[units: participants]
 		  10     10  
Post-dose PC20  
[units: mg/mL]
Geometric Mean ( 95% Confidence Interval ) 		  7  
  ( 2 to 22 )   		  16  
  ( 5 to 45 )  

No statistical analysis provided for Post-dose PC20



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

Measure Type Secondary
Measure Title FEV1
Measure Description The forced expiratory volume in the first second, expressed as a percent predicted.
Time Frame 1 hour after dose  
Safety Issue No  

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.
Of the 12 subjects who qualified for randomization, 2 had a PC20 greater than 128 mg/mL (the maximum concentration of methacholine administered), after receiving 12 mcg of formoterol. Therefore, they were discontinued from the study since their PC20 would not be measurable with a higher dose of formoterol.

Reporting Groups
  Description
12 Mcg of Formoterol low dose
24 Mcg of Formoterol high dose

Measured Values
    12 Mcg of Formoterol     24 Mcg of Formoterol  
Number of Participants Analyzed  
[units: participants]
 		  10     10  
FEV1  
[units: percent predicted]
Mean ± Standard Deviation 		  88  ± 12     91  ± 10  

No statistical analysis provided for FEV1




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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.


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
none  


Results Point of Contact:  
Name/Title: Dr. Leslie Hendeles
Organization: University of Florida Asthma Research Lab
phone: 352-273-6027
e-mail: hendeles@cop.ufl.edu


Publications:


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00643578     History of Changes
Other Study ID Numbers: Ivax-65307
Study First Received: March 20, 2008
Results First Received: August 5, 2011
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration