Induced Sputum Study (0000-065)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623714
• Other study ID #: 0000-065
• Secondary ID: 0652008_509
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2008
• Last updated: April 15, 2015
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL)		Baseline and 24 hours post allergen challenge	No
Secondary	Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL)		Baseline and 24 hours post allergen challenge	No