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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550797

Enrollment

Registered

2007-10-30

Start date

2008-01-31

Completion date

2008-10-31

Last updated

2013-11-20

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

Conditions

Allergic Asthma

Keywords

Steroid-naive, non-smokers, Mild to moderate allergic asthmatic adults

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALTPI ASM8

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

BIOLOGICALplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response	Safety (Trial duration) + LAR (Day 14)

Secondary

Measure	Time frame
Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma	study duration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026