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Ivacaftor for Chronic Obstructive Pulmonary Disease
Study Summary
This trial is testing a drug called Ivacaftor to see if it is safe and effective for treating COPD, chronic bronchitis, and other CFTR-related disorders. The study is small, with only 40 patients, and is double-blind, meaning that neither the patients nor the doctors will know who is receiving the drug or the placebo.
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic Bronchitis
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Frequently Asked Questions
Am I eligible to partake in this research endeavor?
"Applicants for this clinical trial should suffer from chronic bronchitis, and be within the 40-80 year old range. Approximately 40 individuals will receive admission to the study."
In what circumstances is Ivacaftor typically administered?
"Ivacaftor has been formulated to treat an ivacaftor-responsive cftr mutation, homozygous for f508del mutation in the cftr gene and cystic fibrosis (cf)."
Does this research project offer any innovative insights?
"Since it's inception in 2015, Ivacaftor has been subject to multiple clinical trials. The initial research was conducted by Vertex Pharmaceuticals Incorporated and involved 1044 participants. On the back of positive Phase 3 results, there are now 21 ongoing studies being run across 23 countries and 109 cities worldwide."
Can you summarize the primary aims of this investigation?
"This study will assess the safety of ivacaftor by examining abnormal serum chemistry from Screening to Day 98 as its primary objective. Secondary objectives include measuring respiratory function with post-bronchodilator spirometry and assessing patient wellbeing through San Diego Shortness of Breath Questionnaire (SOBQ) and St. George Respiratory Questionnaire (SGRQ), both of which have a Minimum Clinically Important Difference (MCID) score of 5 and 4 respectively."
Is there still availability for participants in this trial?
"According to the information hosted online at clinicaltrials.gov, this trial is actively seeking participants that meet its criteria. It was first posted on March 16th 2017 and most recently modified on March 24th 2022."
Could you provide information regarding any other investigations conducted with Ivacaftor?
"At present, 21 medical studies are underway to assess Ivacaftor's efficacy. Of those trials, 14 occupy Phase 3 while the remainder of investigations occur at 1015 sites across Bochum and California."
Does this research encompass geriatric participants?
"This trial includes individuals aged 40 or older, but not exceeding 80 years in age."
Has the FDA sanctioned Ivacaftor for medical use?
"Ivacaftor is believed to be relatively safe but efficacy has not been fully explored, so it scored a 2 on Power's scale of 1-3."
How many individuals are currently eligible for this experiment?
"Affirmative, information from clinicaltrials.gov reveals that the clinical trial is still enrolling participants. First posted on March 16th 2017 and most recently updated on March 24th 2022, this medical experiment requires 40 individuals to be recruited at a single site."
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