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Sponsored by: |
Aerovance, Inc. |
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Information provided by: | Aerovance, Inc. |
ClinicalTrials.gov Identifier: | NCT00801853 |
A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group, repeated-dose study in male and female patients with moderate to severe asthma in which patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared to placebo. Incidence of asthma exacerbation is the primary endpoint.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Aerovant Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIb Study to Investigate the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients Not Fully Controlled on Current Therapy |
Estimated Enrollment: | 424 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Aerovant 1: Experimental
Aerovant 1mg bid
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Drug: Aerovant
Aerovant 1mg bid (dry powder)
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Aerovant 2: Experimental
Aerovant 3mg bid
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Drug: Aerovant
Aerovant 3mg bid (dry powder)
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Aerovant 3: Experimental
Aerovant 10mg bid
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Drug: Aerovant
Aerovant 10mg bid (dry powder)
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Placebo Control: Placebo Comparator
Placebo Control
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Other: placebo
placebo control (dry powder)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1). 4) Female patient is pregnant, breastfeeding, or not using an adequate method of contraception.
5) Patient has a clinically relevant medical history of very severs asthma that would preclude steroid reduction or sufficient compliance with the protocol. 6) Patient uses concomitant medications, including herbal, over-the-counter, or prescription medicines that, in the opinion of the Investigator, may affect the outcome of study endpoints and/or well-being of the patient. 7) Patient has a history of alcohol or substance abuse within 2 years of Screening (Visit 1).
8) Patient consumes more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of beer). 9) Patient cannot communicate reliably with the Investigator or is unlikely to cooperate with the requirements of the study.
10) Patient has previously taken AEROVANT™ or another formulation of AER 001 (e.g., BAY 16-9996, pitrakinra).
11) Patient has participated in any clinical trial involving use of an investigational drug within 12 weeks of first dose of study drug.
Contact: Alex Bowden | 510-549-5514 | alex.bowden@aerovance.com |
Principal Investigator: | Sally Wenzel, M.D. | UPMC |
Responsible Party: | Aerovance, Inc. ( Babatunde Otulana, M.D. ) |
Study ID Numbers: | PPD/2007/AER 001 DPI/2b |
Study First Received: | December 1, 2008 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00801853 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
asthma allergy atopy atopic wheeze |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |