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

NCT ID: NCT00550797

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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.

Conditions

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Allergic Asthma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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No.1 ASM8 (oligonucleotide)

TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation

Group Type EXPERIMENTAL

TPI ASM8

Intervention Type BIOLOGICAL

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

Phosphate Buffer solution

Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

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

Interventions

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TPI ASM8

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

Intervention Type BIOLOGICAL

placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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i3 Research

INDUSTRY

Sponsor Role collaborator

Syntara

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

Kings College Hospital, London, United Kingdom

Rene Pageau, M.Sc.Pharm

Role: STUDY_DIRECTOR

Topigen Pharmaceuticals, Montreal, Quebec/Canada

Pierluigi Paggiaro, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Pisa, Pisa, Italy

Dave Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Evaluation Unit, Manchester, UK

Peter J. Sterk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam, Amsterdam, The Netherlands

Piero Maestrelli, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Padova, Padova, Italy

Locations

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King's College inLondon

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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TPI ASM8-205

Identifier Type: -

Identifier Source: org_study_id