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

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Pharmaxis

Status and phase

Completed
Phase 2

Conditions

Allergic Asthma

Treatments

Biological: placebo
Biological: TPI ASM8

Study type

Interventional

Funder types

Industry

Identifiers

NCT00550797
TPI ASM8-205

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

18 participants in 2 patient groups, including a placebo group

No.1 ASM8 (oligonucleotide)
Experimental group
Description:
TPI ASM8 1mg/mL in phosphate buffered saline (PBS) solution; 1 mg will be administered daily (morning) by inhalation
Treatment:
Biological: TPI ASM8
Phosphate Buffer solution
Placebo Comparator group
Description:
Placebo solution (PBS) will be administered daily in the form of 1 mL of PBS (phosphate buffered saline) by inhalation
Treatment:
Biological: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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