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TERMINATEDPHASE1

Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and Chronic Obstructive Pulmonary Disease (COPD) Patients (P05567 AM7)

Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled, Incomplete Crossover, Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and COPD Patients

NCT01068145•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1
•Subject of either sex and of any race between the age of 18 and 55 years, with a BMI (weight \[kg\]/height \[m2\]) between 19 and 32.
•Subject must have a FEV1 ≥ 80 % of predicted value.
•Subject must be nonsmoker (including cigarettes, cigars and pipes) or exsmoker who has stopped smoking for at least 6 months (smoking history ≤ 5 pack years).
•Subject's clinical laboratory tests (CBC, blood chemistry, urinalysis) must be within normal limits. Subjects must have a neutrophil count of \>2.0 x 109/L. (also Part 2)
•Subject must be free of any clinically significant disease that would interfere with the study evaluations (also Part 2).
•Screening ECG conduction intervals must be within gender specific normal range; QTcB males ≤430 msec and females ≤450 msec (also Part 2).
•Vital sign measurements must be: a) oral body temperature, between 35.0°C and 37.5°C; b) systolic blood pressure, 90 to 140 mm Hg (160 mm Hg, Part 2); c) diastolic blood pressure, 45 to 90 mm Hg (100 mm Hg, Part 2); d) pulse rate, 40 to 100 bpm.
•Subject and partner(s) must be using an accepted method of contraception during the trial through 2 months post-treatment (also Part 2).
•Prior to randomization, subject must be a responder to ozone (also Part 2).
+5 more criteria

Exclusion Criteria

•Part 1 and Part 2
•Female subject who is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
•Subject with history of seasonal or perennial allergic rhinitis (ie, season for specific allergen).
•Subject who has an allergy or a contraindication to excipients in placebo or SCH 527123 formulations or salbutamol.
•Surgical or medical condition (history or presence) which might alter the ADME of the drug: a) inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; b) major gastrointestinal tract surgery, ie, gastrectomy, gastroenterostomy, or bowel resection; c) pancreatic injury or pancreatitis; d) liver disease or injury; e) impaired renal function indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or f) urinary obstruction or difficulty in voiding.
•Subject who has any infectious disease within 4 weeks prior to drug administration.
•Subject who is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
•Subject who has a positive screen for drugs with a high potential for abuse (Screening and/or treatment period).
•Subjects with a history of mental instability or who have been treated for mood disorder.
•Subject with a history of alcohol or drug abuse in the past 2 years.
+7 more criteria

Key Dates

Start Date

February 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

March 26, 2015

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

SCH 527123

DRUG

SCH 527123

DRUG

SCH 527123

DRUG

SCH 527123

DRUG

Placebo

DRUG

SCH 527123

DRUG

SCH 527123

DRUG

SCH 527123

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and Chronic Obstructive Pulmonary Disease (COPD) Patients (P05567 AM7)

Inclusion Criteria

Exclusion Criteria

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