Early Airway Response to Allergen in Asthmatics (0000-176)
Information source: Merck
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: nedocromil (Drug); Comparator: montelukast (Drug); Comparator: mometasone (Drug); Comparator: twisthaler placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
This study will assess the Early Airway Response (EAR) associated change in forced
expiratory volume in one second (FEV1) and plasma 9a-11ß-PGF2 ('9P') after single dose
pretreatment of nedocromil, montelukast, and mometasone.
Clinical Details
Official title: A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Change in FEV1Change in plasma 9P Allergen-induced change in plasma 9P
Secondary outcome: Allergen-induced changes in urinary 9PAllergen-induced changes in urinary LTE4 Allergen-induced changes in sputum LTC4+LTD4+LTE4
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has a history of mild to moderate Asthma
- Patient is in good general health (except for asthma)
- Patient is stable and free of respiratory infection
- Patient is a nonsmoker
- If female, patient is highly unlikely to conceive (Patient is surgically sterilized,
postmenopausal, or agrees to use 2 acceptable methods of birth control)
Exclusion Criteria:
- Patient is a nursing mother
- Patient has recent or ongoing upper or lower respiratory tract infection
- Patient is unable to refrain from or anticipates the use of any prescription and
non-prescription drugs
- Patient consumes excessive amounts of alcohol or caffeine
- Patient has a history of stroke, chronic seizures, or major neurological disorder
- Patient has a history of cancer
- Patient received a vaccination within the past 3 weeks
Locations and Contacts
Merch Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452341
Additional Information
Starting date: June 2010
Last updated: September 24, 2010
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