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Tiotropium Bromide Inhalation Powder for Chronic Obstructive Pulmonary Disease (COPD) (ARBORUS Trial)
ARBORUS Trial Summary
This trial tests if an inhalable powder can effectively treat breathing problems in people with COPD.
- Chronic Obstructive Pulmonary Disease
ARBORUS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ARBORUS Trial Design
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Who is running the clinical trial?
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- You have glaucoma or a history of glaucoma in your family.You had a respiratory or urinary tract infection or illness within the past 8 weeks before the screening visit.You have had problems with alcohol or drug abuse in the past two years.You have a history of certain medical conditions that would make it risky to use a particular type of medication.You have had a severe episode of COPD in the past that was life-threatening and required a breathing tube.You have been diagnosed with pulmonary hypertension or show signs of heart failure, such as swollen neck veins or fluid buildup. You also need to use oxygen for more than 12 hours every day.You should not have had any infections in your nose, throat, or lungs before the study starts.You have difficulty or a past history of trouble urinating.Your immune system is not working properly.You have had allergies or bad reactions to certain types of medications used for breathing problems or lactose/milk proteins.You haven't had any severe worsening of your COPD that required going to the emergency room or being hospitalized. You also haven't had to use a lot of rescue medication or take antibiotics or corticosteroids for your COPD during the study.You have smoked cigarettes for a total of at least 10 years, whether currently or in the past.
- Group 1: Placebo
- Group 2: Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)
- Group 3: Treatment B: 18 mcg of Reference Product (Spiriva)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this clinical trial open to participants of advanced age?
"The parameters for this trial stipulate that individuals aged between 40 to 75 are qualified. 33 trials exist for younger demographic and 413 trials accommodate those over 65."
Has the FDA granted authorization for Treatment A of 18 mcg tiotropium bromide inhalation powder?
"Our team at Power assessed the safety of Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder) as a 3, given its Phase 3 status and available clinical data for both efficacy and security."
What characteristics make someone a suitable participant for this research project?
"This clinical trial, which is recruiting up to 335 patients, requires that all participants possess chronic obstructive pulmonary disease and are between 40 and 75 years of age."
Has this clinical trial been implemented in numerous medical centers across the USA?
"For this medical study, 33 sites are available for patient enrolment. Examples of locations include Southwest General Heathcare in Fort Myers, SIMED Health in Gainesville, and Clinical Research Solutions in Kissimmee."
Is enrollment still available for this trial?
"As indicated by clinicaltrials.gov, this trial is not presently accepting participants. The original post date was August 17th 2022 and the listing was last modified on August 3rd 2023. Nevertheless, there are currently 452 other studies recruiting patients at this time."
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What site did they apply to?
What portion of applicants met pre-screening criteria?
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