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

Allergic Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550797
• Other study ID #: TPI ASM8-205
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2007
• Last updated: November 18, 2013
• Start date: January 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2013
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: Medicines Evaluation Board (MEB)Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Biological:
• TPI ASM8
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
• placebo
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

Locations

Country	Name	City	State
United Kingdom	King's College inLondon	London

Sponsors (2)

Lead Sponsor	Collaborator
Pharmaxis	i3 Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

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