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Study Summary
This trial compares the effects of two different inhalers in people with asthma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Who is running the clinical trial?
Media Library
- I am a woman who can have children and my pregnancy test is negative.My lung function, measured before using a bronchodilator, is within the required range.I haven't taken any immunosuppressive drugs in the last 3 months and don't plan to start any during the study.I have been using a quick-relief asthma inhaler as my only treatment for at least 4 weeks.I haven't taken any corticosteroids in the last 3 months.I am either male or female.I am a current smoker or have a history of heavy smoking, including vaping and water pipes.My lung function returns to near normal within an hour after a specific breathing test.You have already been part of this study before.I have had an urgent visit for asthma in the last 4 weeks.I have a lung condition that is not asthma.I haven't taken any experimental drugs recently.I reacted strongly to a breathing test with mannitol.You have had allergy shots in the last 3 months.I have signed a consent form for optional genetic research.You are allergic to certain medications used to treat breathing problems.I have used inhaled corticosteroids within the last month.I was diagnosed with asthma by a doctor more than 6 months ago.
- Group 1: Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2
- Group 2: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many people can take part in this experiment at most?
"That is correct. The listings on clinicaltrials.gov show that the trial is currently underway, with the most recent update having been made on October 24th, 20202. This study has one site and is looking for 76 individuals to participate."
Does this research include elderly participants?
"This trial is open to participants that fall between 18 and 130 years of age. For perspective, there are 120 trials for individuals younger than 18 and 211 for seniors above 65."
Could you please contrast the levels of danger for patients between Treatment B and Treatment A?
"PT007 and PT027 have both undergone extensive clinical testing and received a score of 3 for safety."
Who meets the screening requirements for this experiment?
"This clinical trial is seeking to enroll 76 individuals that have been diagnosed with asthma by a medical professional in the last 6 months. There are several key requirements for applicants, which are as follows: a need for SABA medication usage for at least 4 weeks leading up to the screening visit, pre-bronchodilator FEV1 must be above 1.5L and 60-90% of what is considered normal, positive response to mannitol challenge test, ability to return to baseline FEV1 within an hour after taking 4 inhalations of PT007, capability to follow study procedures according to the judgement of the investigator conducting"
Are patients still being sought for this experiment?
"The clinical trial is recruiting patients, as indicated by the information available on clinicaltrials.gov. This study was originally posted on September 28th, 2020 and was last edited on October 24th, 2020."
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