Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma
This study has been completed.
Sponsor:
Pharmaxis
Collaborator:
i3 Research
Information provided by (Responsible Party):
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00550797
First received: October 26, 2007
Last updated: November 30, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Asthma |
Biological: TPI ASM8 Biological: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pharmaxis:
Primary Outcome Measures:
- Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response [ Time Frame: Safety (Trial duration) + LAR (Day 14) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | January 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550797
Locations
| United Kingdom | |
| King's College inLondon | |
| London, United Kingdom, SE1 9RT | |
Sponsors and Collaborators
Pharmaxis
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 |
More Information
No publications provided
| Responsible Party: | Pharmaxis |
| ClinicalTrials.gov Identifier: | NCT00550797 History of Changes |
| Other Study ID Numbers: | TPI ASM8-205 |
| Study First Received: | October 26, 2007 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: Medicines Evaluation Board (MEB) Italy: Ministry of Health |
Keywords provided by Pharmaxis:
|
Steroid-naive, non-smokers Mild to moderate allergic asthmatic adults |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013