NCT00585260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for early_phase_1 asthma

Timeline
Completed

Started Dec 2007

Typical duration for early_phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2010

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

December 26, 2007

Last Update Submit

August 14, 2019

Conditions

Asthma

Keywords

asthmabronchoprovocation challenge testmannitolmethacholine

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial).

    At 6 weeks, 20 weeks, and 32 weeks

Other Outcomes (1)

  • Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial

    Baseline

Study Arms (1)

Exploratory Mannitol

EXPERIMENTAL

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

Drug: mannitol

Interventions

mannitolDRUG

indirect mannitol challenge

Exploratory Mannitol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all subjects randomized to the BASALT protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 22968888BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Christine A Sorkness, Pharm.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 3, 2008

Study Start

December 1, 2007

Primary Completion

February 16, 2010

Study Completion

February 16, 2010

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

US(1)