Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma - Full Text View

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 II

MedlinePlus related topics:

Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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

Further study details as provided by Topigen Pharmaceuticals:

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 ]

Estimated Enrollment:	18
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator Placebo 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

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	Recruiting
	London, United Kingdom, SE1 9RT
	Contact: Marianne Morgan +44 (0) 20 7848 6153 Marianne.morgan@kcl.ac.uk
	Principal Investigator: Brian O'Connor, MD

Sponsors and Collaborators

Topigen Pharmaceuticals

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

Responsible Party:	Topigen Pharmaceuticals ( Rene Pageau- Senior Director )
Study ID Numbers:	TPI ASM8-205
First Received:	October 26, 2007
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00550797
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Italy: Ministry of Health

Keywords provided by Topigen Pharmaceuticals:

Steroid-naive, non-smokers

Mild to moderate allergic asthmatic adults

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Topigen Pharmaceuticals i3 Research
Information provided by:	Topigen Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00550797