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OpenTrials
Completed

NCT Number: NCT00890175

Staccato Loxapine Pulmonary Safety in Patients With Asthma

The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.

Completed

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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 1

Primary location

Allergy and Asthma Medical Group & Research Center, A.P.C.

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.

Exclusion criteria

  • History of COPD, or any other acute or chronic pulmonary disease

Treatment and study plan

Inhaled loxapine @ 0 & 10 h

Drug

10 mg, 2 doses, 10 hours apart

Other names: ADASUVE

Inhaled placebo @ 2 & 10 hours

Drug

placebo, 2 doses, 10 hours apart

Other names: ADASUVE PLACEBO

Primary outcomes

  1. Change in FEV1 from baseline by spirometry

    Time frame: at each post-treatment time point (15 min to 34 hr)

Secondary outcomes

  1. Change in FVC from baseline by spirometry

    Time frame: at each post-treatment time point (15 min to 34 hr)

  2. Treatment emergent adverse events

    Time frame: Post-treatment time points

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

Pulmonary Safety of Staccato® Loxapine for Inhalation in Subjects With Asthma

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2009
Registry last updated
Mar 15, 2017

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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