Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01642745

Enrollment

Registered

2012-07-17

Start date

2011-11-30

Completion date

2013-02-28

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGMethacholine (Provocholine)

two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL

DRUGMannitol (Aridol)

single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* stable controlled asthma

Exclusion criteria

* pregnancy * use of asthma therapies other than bronchodilator therapy

Design outcomes

Primary

Measure	Time frame	Description
Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing	Visit 1 (Day 1)	The two minute tidal breathing PC20 with be captured once at visit 1.
airway responsiveness (PD15) to inhaled mannitol	Visit 2 = up to 13 days	The PD15 to mannitol will be captured once at either visit 2 or visit 3.
Airway responsiveness (PC20) to deep inhalation methacholine	Visit 3 = up to 14 days	The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026