Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay
NCT ID: NCT00643578
Last Updated: 2011-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2008-03-31
2009-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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2
a single dose of 24 mcg of formoterol
formoterol
a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
Dry Powder Inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
1
a single dose of 12 mcg of formoterol
formoterol
a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
Dry Powder Inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
Interventions
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formoterol
a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
formoterol
a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
Dry Powder Inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Leslie Hendeles, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida Asthma Research Lab
Gainesville, Florida, United States
Countries
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References
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Ahrens RC, Harris JB, Milavetz G, Annis L, Ries R. Use of bronchial provocation with histamine to compare the pharmacodynamics of inhaled albuterol and metaproterenol in patients with asthma. J Allergy Clin Immunol. 1987 Jun;79(6):876-82. doi: 10.1016/0091-6749(87)90235-1.
Blake KV, Hoppe M, Harman E, Hendeles L. Relative amount of albuterol delivered to lung receptors from a metered-dose inhaler and nebulizer solution. Bioassay by histamine bronchoprovocation. Chest. 1992 Feb;101(2):309-15. doi: 10.1378/chest.101.2.309.
Hendeles L, Beaty R, Ahrens R, Stevens G, Harman EM. Response to inhaled albuterol during nocturnal asthma. J Allergy Clin Immunol. 2004 Jun;113(6):1058-62. doi: 10.1016/j.jaci.2004.03.046.
Parameswaran KN, Inman MD, Ekholm BP, Morris MM, Summers E, O'Byrne PM, Hargreave FE. Protection against methacholine bronchoconstriction to assess relative potency of inhaled beta2-agonist. Am J Respir Crit Care Med. 1999 Jul;160(1):354-7. doi: 10.1164/ajrccm.160.1.9812035.
Ahrens RC, Hendeles L, Clarke WR, Dockhorn RJ, Hill MR, Vaughan LM, Lux C, Han SH. Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler. A bioassay using methacholine. Am J Respir Crit Care Med. 1999 Oct;160(4):1238-43. doi: 10.1164/ajrccm.160.4.9806101.
Creticos PS, Adams WP, Petty BG, Lewis LD, Singh GJ, Khattignavong AP, Molzon JA, Martinez MN, Lietman PS, Williams RL. A methacholine challenge dose-response study for development of a pharmacodynamic bioequivalence methodology for albuterol metered- dose inhalers. J Allergy Clin Immunol. 2002 Nov;110(5):713-20. doi: 10.1067/mai.2002.129036.
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
Asmus MJ, Vaughan LM, Hill MR, Chesrown SE, Hendeles L. Stability of frozen methacholine solutions in unit-dose syringes for bronchoprovocation. Chest. 2002 May;121(5):1634-7. doi: 10.1378/chest.121.5.1634.
Other Identifiers
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Ivax-65307
Identifier Type: -
Identifier Source: org_study_id