Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

Asthma Clinical Trial

Official title:

Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585260
• Other study ID #: H-2007-0071
• Secondary ID: 144QK18
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2007
• Est. completion date: February 16, 2010

Study information

• Verified date: August 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 16, 2010
• Est. primary completion date: February 16, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• mannitol
indirect mannitol challenge

Locations

Country	Name	City	State
United States	University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI), Pharmaxis

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial	To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements and methacholine bronchoprovocation performance as collected in the BASALT trial.	Baseline
Primary	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