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OpenTrials
Completed

NCT Number: NCT00730977

A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.

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Key information

Conditions

Healthy Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Prince Alfred Hospital

Sydney, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy or bronchiectatic; 18 years and over

Exclusion criteria

  • uncontrolled asthma, unstable

Treatment and study plan

dry powder inhaled mannitol

Drug

single doses of 40 mg, 70 mg and 100 mg

Primary outcomes

  1. tolerability

    Time frame: immediately and 10 mins post dose

Secondary outcomes

  1. respiratory symptoms, FEV1

    Time frame: pre-dose, immediately and 10 mins post dose

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With Bronchiectasis.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 8, 2008
Registry last updated
Sep 18, 2009

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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