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

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Baseline Characteristics

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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

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1. Primary:

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

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2. Secondary:

FEV1 [ Time Frame: 1 hour after dose ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

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.

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.

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. Erratum in: J Allergy Clin Immunol. 2006 Apr;117(4):773.

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.

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.

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.

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. 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.

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.

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

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