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Induced Sputum Study
This study is currently recruiting participants.
Verified by Merck, January 2009
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00623714
  Purpose

The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics.


Condition Intervention Phase
Asthma
Drug: Comparator: fluticasone
Drug: Comparator: Comparator: placebo
Phase I

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone Fluticasone propionate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title: A Randomized, Placebo-Controlled, Crossover Study to Assess the Effects of Inhaled Fluticasone on Markers of Inflammation After Allergen Challenge in Patients With Allergic Asthma

Further study details as provided by Merck:

Primary Outcome Measures:
  • To assess the changes from baseline in allergen-induced inflammatory markers (for example, TNF-alpha, IL-13) in sputum [ Time Frame: At 7and 24 hours post allergen challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of doses of fluticasone on the change in allergen-induced inflammatory markers (for example, TNF-alpha, IL-13) in induced sputum. [ Time Frame: At 7 and at 24 hours post allergen challenge ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental
study medication + Pbo
Drug: Comparator: fluticasone
Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
Drug: Comparator: Comparator: placebo
Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
Arm 2: Experimental
Pbo + study medication
Drug: Comparator: fluticasone
Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.
Drug: Comparator: Comparator: placebo
Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a history of mild to moderate persistent allergic asthma for at least 6 months with typical symptoms, including cough, wheezing, and shortness of breath, is clinically stable and has no history of recent respiratory tract infection within 3 weeks of the start of the study
  • Patient, aside history of asthma, is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
  • Patient is able to perform reproducible pulmonary function test
  • Patient has an allergic response to house dust mite allergen, demonstrates a positive early and late phase response to an inhaled allergen challenge (as defined by a bronchoconstrictive response)
  • Patient is a nonsmoker for at least 12 months
  • Patients must have less than or equal to 10 pack years of smoking to be included. (10 pack years = one pack per day for 10 years.) Patients who have discontinued smoking for at least 10 months may be enrolled at the discretion of the investigator
  • Patient is willing to avoid strenuous physical activity (i.e., strenuous or unaccustomed weight lifting, running, bicycling, etc.) for 72 hours prior to each visit when laboratory safety tests are obtained and 48 hours prior to allergen challenge

Exclusion Criteria:

  • Patient has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the patient by their participation in the study
  • Patient has taken oral corticosteroids within 8 weeks or inhaled corticosteroids/nasal corticosteroids within 4 weeks of screening and/or during the study
  • Patient has a history of stroke, chronic seizures, or major neurological disorder
  • Patient has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory (other than asthma), or genitourinary abnormalities or diseases, or has a history of neoplastic disease
  • Patient is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study, including prescription and non-prescription drugs or herbal remedies prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit
  • Patient consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages per day or >21 drink equivalents per week
  • Patient consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623714

Locations
Netherlands
Merck Sharp & Dohme B.V. Recruiting
Haarlem, Netherlands, 2031 BN
Contact: Caroline Doornebos     31-23-515-3362        
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2008_509, 065
Study First Received: February 11, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00623714  
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity
Inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009