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

November 18, 2013 updated by: Pharmaxis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • King's College inLondon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No.1 ASM8 (oligonucleotide)
TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation
Biological: TPI ASM8
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each
Placebo Comparator: Phosphate Buffer solution
Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation
Biological: placebo
Administered with the I-Neb device from Respironics once daily by inhalation over 2 treatment periods of 14 days each

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: study duration
study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaxis

Collaborators

i3 Research

Investigators

  • Principal Investigator: Brian O'Connor, MD, Kings College Hospital, London, United Kingdom
  • Study Director: Rene Pageau, M.Sc.Pharm, Topigen Pharmaceuticals, Montreal, Quebec/Canada
  • Principal Investigator: Pierluigi Paggiaro, Prof, University of Pisa, Pisa, Italy
  • Principal Investigator: Dave Singh, MD, Evaluation Unit, Manchester, UK
  • Principal Investigator: Peter J. Sterk, MD, University of Amsterdam, Amsterdam, The Netherlands
  • Principal Investigator: Piero Maestrelli, Prof., University of Padova, Padova, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 26, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPI ASM8-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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