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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

March 20, 2008
November 29, 2011
March 2008
January 2009   (final data collection date for primary outcome measure)
Post-dose PC20 [ Time Frame: 3-7 days after visits 1 and 2 ] [ Designated as safety issue: No ]
The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.
post-dose PC20 [ Time Frame: 3-7 days after visits 1 and 2 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00643578 on ClinicalTrials.gov Archive Site
FEV1 [ Time Frame: 1 hour after dose ] [ Designated as safety issue: No ]
The forced expiratory volume in the first second, expressed as a percent predicted.
FEV1 [ Time Frame: 1 hour after dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay
A Pilot Study to Evaluate the Dose-response of Inhaled Formoterol to Inhibit Airway Responsiveness to Methacholine in Patients With Mild Asthma

The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.

During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed.

During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test.

At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Asthma
  • Drug: formoterol
    a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
  • Drug: formoterol
    a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
  • Device: Dry Powder Inhaler (Twisthaler)
    subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
  • Active Comparator: 2
    a single dose of 24 mcg of formoterol
    Interventions:
    • Drug: formoterol
    • Device: Dry Powder Inhaler (Twisthaler)
  • Active Comparator: 1
    a single dose of 12 mcg of formoterol
    Interventions:
    • Drug: formoterol
    • Device: Dry Powder Inhaler (Twisthaler)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-smoking male or female 18 60 years of age, with a previous diagnosis of asthma that has been stable for at least 4 weeks and which is unlikely to exacerbate during the study because of, for example, seasonal allergen exposure. Women of childbearing age must not be pregnant or nursing, and must be using an acceptable method of contraception.
  • Ability to perform ATS/ERS-acceptable and reproducible spirometry7
  • Screening FEV1 ≥70% of predicted for height, age, sex, and race when short-acting inhaled bronchodilators are withheld for at least 6 hours
  • At least a 20% decrease in FEV1 after inhaling ≤4 mg/mL of methacholine (i.e., a PC20 FEV1 ≤4 mg/mL)
  • Can be taught to use the dry powder device in accordance with the product's medication guide.
  • If using an oral inhaled or intranasal corticosteroid, dosage must be stable for at least 4 weeks.

Exclusion Criteria:

  • Allergy or sensitivity to inhaled methacholine, formoterol or to other β2 agonists
  • Intolerance to other components of the inhaler or sensitivity to milk proteins
  • Cigarette smoking in past year or >10 pack-year smoking history
  • Respiratory tract infection within the last four weeks
  • History of severe asthma attack requiring hospitalization in the previous 12 months
  • Short course of oral and/or systemic corticosteroids in the past 4 weeks
  • Inability to withhold caffeinated beverages for 12 hours or medications for appropriate intervals prior to each methacholine challenge
  • Require treatment with beta-blockers (administered by any route), MAO inhibitors, tricyclic antidepressants, and/or maintenance therapy with systemic corticosteroids
  • History and/or presence of pulmonary conditions (including but not limited to cystic fibrosis and bronchiectasis) other than asthma
  • History of clinically-significant cardiovascular, renal, neurologic, liver or endocrine dysfunction. Patients with well-controlled hypertension, hypercholesterolemia or diabetes will not be excluded.
  • If female, a positive urine β-HCG test
  • Known or suspected substance abuse (e.g., alcohol, marijuana, etc.) and/or any other medical or psychological conditions that in the investigator's opinion should preclude study enrollment.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643578
Ivax-65307
No
University of Florida
University of Florida
Teva Branded Pharmaceutical Products, R&D Inc.
Principal Investigator: Leslie Hendeles, PharmD University of Florida
University of Florida
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP