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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-11-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 FEV1

Change in plasma 9P

Allergen-induced change in plasma 9P

Secondary outcome:

Allergen-induced changes in urinary 9P

Allergen-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

Page last updated: October 04, 2010

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