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Completed

NCT Number: NCT00550797

Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma

The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

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Key information

Conditions

Allergic Asthma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King's College inLondon

London, SE1 9RT, United Kingdom

About this study

Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women 18 to 65 years of age
  • Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria
  • History of episodic wheeze and shortness of breath

Exclusion criteria

  • Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks
  • Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants

Treatment and study plan

TPI ASM8

Biological

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Placebo

Biological

Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Primary outcomes

  1. Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response

    Time frame: Safety (Trial duration) + LAR (Day 14)

Secondary outcomes

  1. Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma

    Time frame: study duration

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Collaborators

  • i3 Research

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 30, 2007
Registry last updated
Nov 20, 2013

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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