Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Asthma Clinical Trial

Official title:

Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642745
• Other study ID #: IIS-A-522
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2012
• Last updated: October 26, 2016
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: October 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The study will compare the airway responses to two bronchoconstricting agents, mannitol and methacholine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• stable controlled asthma

Exclusion Criteria:

• pregnancy

• use of asthma therapies other than bronchodilator therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Methacholine (Provocholine)
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL
• Mannitol (Aridol)
single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).
• Methacholine (Provocholine)
two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing	The two minute tidal breathing PC20 with be captured once at visit 1.	Visit 1 (Day 1)	No
Primary	airway responsiveness (PD15) to inhaled mannitol	The PD15 to mannitol will be captured once at either visit 2 or visit 3.	Visit 2 = up to 13 days	No
Primary	Airway responsiveness (PC20) to deep inhalation methacholine	The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.	Visit 3 = up to 14 days	No