Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

NCT ID: NCT00585260

Last Updated: 2019-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-02-16

Brief Summary

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This is an ancillary study conducted as part of the BASALT trial \[NCT00495157\].

The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Exploratory Mannitol

This is an exploratory / ancillary study open to all participants in the BASALT trial \[NCT00495157\] who consented to undergo mannitol bronchoprovocation procedures during the 36 week treatment period

Group Type EXPERIMENTAL

mannitol

Intervention Type DRUG

indirect mannitol challenge

Interventions

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mannitol

indirect mannitol challenge

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all subjects randomized to the BASALT protocol

Exclusion Criteria

* positive urine pregnancy test
* requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntara

INDUSTRY

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine A Sorkness, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893.

Reference Type BACKGROUND
PMID: 22968888 (View on PubMed)

Other Identifiers

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144QK18

Identifier Type: -

Identifier Source: secondary_id

H-2007-0071

Identifier Type: -

Identifier Source: org_study_id

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