[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-866-503-6351

Email address

clinicaltrialdisclosure@sunovion.com

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Treatment type

Interventional

Investigational product

Glyocopyrrolate Inhalation Solution administered by Magnair

Phase

Phase 4

Sponsor

Sunovion Respiratory Development Inc.

ClinicalTrials.gov identifier

NCT04155047

Study number

SUN101-402

Understanding clinical trials

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About the study

A clinical study to investigate if a single dose of an approved drug product (glycopyrrolate Inhalation Solution) reduces trapped air in the lungs of participants with chronic obstructive pulmonary disease. This study is accepting male and female participants over the age of 40. The study will be conducted at one site located in the United States.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Subject is male or female and ≥ 40 years of age at Screening with a confirmed diagnosis of COPD. Subject must have the ability to comprehend the informed consent form and be willing to provide informed consent. Subject must possess an educational level and degree of understanding of English that enables them to communicate suitably with the Investigator and the study coordinator. Subject has a postbronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 30% and < 80% of predicted normal at Screening. Subject has a postbronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio of < 0.70 at Screening. Subject has a RV ≥ 130% predicted value at Screening (prior to reversibility testing) Subject is a current or former smoker with at least 10 pack-years of cigarette smoking history at Screening. Subject has a score of ≥ 2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening. Subject, if female of child bearing potential, must have a negative serum pregnancy test at Screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 30 days prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, eg, condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence. A follicle stimulating hormone (FSH) test will be used to confirm menopause in postmenopausal females. Subject is willing and able to attend all study visits and adhere to all study assessments and procedures.
Exclusion criteria
  1. males) or > 470 msec (
  2. females) at Screening, unless discussed with and approved by the Medical Monitor. Subject has a cardiac implanted device (internal defibrillator, pacemaker). Current severe heart failure (New York Heart Association Class
  3. IV) [New York Heart Association, 1994]. Subject has history of malignancies within the past 5 years, with the exception of basal cell carcinoma. Subject has known comorbidities including unstable cardiac, pulmonary, or psychiatric disease, or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject. Subject has participated in another investigational drug study (within 30 days prior to Screening). Subjects who are study site staff members or relatives of study site staff members. Subjects with a history of allergic reaction to glycopyrrolate, tiotropium, albuterol, or any components of the study medications. Subjects with a known allergy to hydrocolloid gel adhesive are excluded from wearing the VitalPatch Biosensor. -Continuation Criteria Subject has not had an exacerbation of COPD. Subject completes the 7-day washout period and continues to withhold restricted medications. In the opinion of the Investigator, the subject has not had any change that would put the safety of the subject at risk through participation.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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