← Back to Search

Bronchodilator

PT027 vs PT007 Inhalers for Asthma

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential must have a negative urine pregnancy test at each study visit
Participants should have pre-bronchodilator FEV1 ≥ 1.5 L and FEV1 ≥ 60% to < 90% predicted normal at Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 8 hours (480 minutes) post mannitol challenge 1
Awards & highlights

Study Summary

This trial compares the effects of two different inhalers in people with asthma.

Who is the study for?
This trial is for adults diagnosed with asthma who have had a specific reaction to mannitol, an airway irritant. They must be using short-acting bronchodilators as their only asthma treatment and not have used certain other medications recently. Pregnant or breastfeeding individuals, heavy smokers, or those with significant health issues besides asthma cannot participate.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of PT027 versus PT007 in treating acute airway obstruction in asthmatic patients. Both drugs are administered after inducing obstruction with mannitol to see which one better improves breathing.See study design
What are the potential side effects?
While the side effects aren't specified here, common reactions to inhalers like PT027 and PT007 may include throat irritation, coughing, headache, or a fast heartbeat. More serious but less common effects could involve allergic reactions or worsening breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who can have children and my pregnancy test is negative.
Select...
My lung function, measured before using a bronchodilator, is within the required range.
Select...
I have been using a quick-relief asthma inhaler as my only treatment for at least 4 weeks.
Select...
I am either male or female.
Select...
My lung function returns to near normal within an hour after a specific breathing test.
Select...
I reacted strongly to a breathing test with mannitol.
Select...
I have signed a consent form for optional genetic research.
Select...
I was diagnosed with asthma by a doctor more than 6 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 hours (480 minutes) post mannitol challenge 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 8 hours (480 minutes) post mannitol challenge 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from mannitol baseline Forced expiratory volume in the first second (FEV1) Area under the curve (AUC [0-60 min]) post-mannitol challenge 1
Secondary outcome measures
Change from mannitol baseline in FEV1 AUC (0-15 min) post-mannitol challenge 1
Change from mannitol baseline in FEV1 at 8 hours post-mannitol challenge 1
Number of participants with Adverse Events (AEs)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2Experimental Treatment2 Interventions
At Visit 2, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10 to 14 days. At Visit 3, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge.
Group II: Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2Experimental Treatment2 Interventions
At Visit 2, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10-14 days. At Visit 3, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,245 Previous Clinical Trials
288,529,143 Total Patients Enrolled
328 Trials studying Asthma
639,964 Patients Enrolled for Asthma

Media Library

PT007 (Bronchodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05555290 — Phase 3
Asthma Research Study Groups: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2, Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2
Asthma Clinical Trial 2023: PT007 Highlights & Side Effects. Trial Name: NCT05555290 — Phase 3
PT007 (Bronchodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555290 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~0 spots leftby Apr 2024