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

NCT00550797 | Completed Phase 2

• 1 other identifier: TPI ASM8-205
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

  study duration

Study Arms (2)

No.1 ASM8 (oligonucleotide)

EXPERIMENTAL

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

Biological: TPI ASM8

Phosphate Buffer solution

PLACEBO COMPARATOR

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

Biological: placebo

Interventions

TPI ASM8 BIOLOGICAL

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

No.1 ASM8 (oligonucleotide)

placebo BIOLOGICAL

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

Phosphate Buffer solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syntara: lead
• i3 Research: collaborator

Study Sites (1)

King's College inLondon

London, London, SE1 9RT, United Kingdom

Location

MeSH Terms

Interventions

TPI ASM8

Study Officials

• Brian O'Connor, MD

  Kings College Hospital, London, United Kingdom

  PRINCIPAL INVESTIGATOR

• Rene Pageau, M.Sc.Pharm

  Topigen Pharmaceuticals, Montreal, Quebec/Canada

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

GB (1)