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CompletedNCT00550797Updated Nov 20, 2013

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

A Phase 2 interventional study of TPI ASM8 and placebo in Allergic Asthma, sponsored by Syntara. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-20.

Sponsored by Syntara · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allergic Asthma

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Keywords

  • Steroid-naive, non-smokers
  • Mild to moderate allergic asthmatic adults
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 18 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Syntara is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • 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

  • 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

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

06

What researchers measure

Primary outcomes

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

    Time frame: Safety (Trial duration) + LAR (Day 14)

Secondary outcomes

  1. 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

07

Study locations

1 site
  • King's College inLondon
    London, SE1 9RT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00550797
Lead sponsor
Syntara
Collaborators
i3 Research
Responsible party
Sponsor
First posted
Oct 30, 2007
Start date
Jan 2008
Primary completion
Jul 2008
Completion
Oct 2008
Last update
Nov 20, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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