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

Primary Purpose

Allergic Asthma

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

TPI ASM8

placebo

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring Steroid-naive, non-smokers, Mild to moderate allergic asthmatic adults

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

King's College inLondon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

No.1 ASM8 (oligonucleotide)

Phosphate Buffer solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00550797

First Posted

October 26, 2007

Last Updated

November 18, 2013

Sponsor

Pharmaxis

Collaborators

i3 Research

1. Study Identification

Unique Protocol Identification Number

NCT00550797

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmaxis

Collaborators

i3 Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No.1 ASM8 (oligonucleotide)

Arm Type

Experimental

Arm Description

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

Arm Title

Phosphate Buffer solution

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

TPI ASM8

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Safety (Trial duration) + LAR (Day 14)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: