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Completed

NCT Number: NCT01642745

Mannitol (Aridol) and Methacholine (Provocholine) Responsiveness

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stable controlled asthma

Exclusion criteria

  • pregnancy
  • use of asthma therapies other than bronchodilator therapy

Treatment and study plan

Methacholine (Provocholine)

Drug

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

Mannitol (Aridol)

Drug

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

Primary outcomes

  1. Airway responsiveness (PC20) to methacholine delivered over two minutes of tidal breathing

    Time frame: Visit 1 (Day 1)

    The two minute tidal breathing PC20 with be captured once at visit 1.

  2. airway responsiveness (PD15) to inhaled mannitol

    Time frame: Visit 2 = up to 13 days

    The PD15 to mannitol will be captured once at either visit 2 or visit 3.

  3. Airway responsiveness (PC20) to deep inhalation methacholine

    Time frame: Visit 3 = up to 14 days

    The PC20 to methacholine (deep inhalation) will be captured once at either visit 2 or visit 3.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Mannitol and Methacholine Responsiveness: Effects of Deep Inhalations

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2012
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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