A Phase 3 clinical study for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Phase 3 clinical study for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

Description

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Details
Clinical Study IdentifierTX137894
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Male or female subjects at least 40 years of age and no older than 80 at Visit 1
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
Current or former smokers with a history of at least 10 pack-years of cigarette smoking
Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using NHANES III reference equations
Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Exclusion Criteria

Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
Current diagnosis of asthma or alpha-1 antitrypsin deficiency
Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment
Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
Congestive heart failure (CHF NYHA Class III/IV)
Clinically significant abnormal 12-lead ECG
Abnormal liver function tests defined as AST, ALT, or total bilirubin = 1.5 times upper limit of normal at Visit 1 and on repeat testing
Cancer not in complete remission for at least five years
History of hypersensitivity to ß2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
Other protocol-defined inclusion/exclusioncriteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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