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Airway Clearance Techniques for Cystic Fibrosis (SPACE-CF Trial)
N/A
Recruiting
Led By Tahuanty Pena, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
treatment with Elexacaftor-Tezacaftor-Ivacaftor for > 90 days prior to enrollment
age > 18 years at the time of recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
SPACE-CF Trial Summary
This trial is investigating whether or not patients with CF will see additional benefits from continuous airway clearance regimens after starting Elexacaftor-Tezacaftor-Ivacaftor therapy.
Who is the study for?
Adults over 18 with Cystic Fibrosis who've been on Elexacaftor-Tezacaftor-Ivacaftor for at least 90 days can join. They must be willing to do airway clearance twice daily for up to 180 days and have had no lung flare-ups in the last month. Smokers, recent regimen changers, those intolerant to certain treatments, or on drugs for NTM or an acute lung issue can't participate.Check my eligibility
What is being tested?
The trial is testing if doing airway clearance exercises every day adds any benefit after starting a CFTR modulator therapy called ETI. It looks at whether this extra effort improves lung function tests and imaging results compared to symptom-driven performance of these exercises.See study design
What are the potential side effects?
While not explicitly stated, side effects may include discomfort from daily airway clearance techniques like coughing or fatigue and potential intolerance issues related to hypertonic saline and Pulmozyme used during the procedures.
SPACE-CF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on Elexacaftor-Tezacaftor-Ivacaftor for over 90 days.
Select...
I am older than 18 years.
SPACE-CF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change in percent predicted FEV1 (ppFEV1) from week 0 to week 12 in symptom driven airway clearance arm
Absolute change in percent predicted FVC (ppFVC) from week 0 to week 12 in symptom driven airway clearance arm
Secondary outcome measures
Absolute change in respiratory symptoms based upon Cystic Fibrosis Questionnaire Revise score
Change in airway colonization with S. aureus or P. aeruginosa
Frequency of performance of airway clearance in symptom driven airway clearance arm
+1 moreSPACE-CF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Symptom drivenExperimental Treatment1 Intervention
Symptom driven performance of airway clearance regimen
Group II: ContinuousActive Control1 Intervention
Continuous performance of baseline daily airway clearance regimen
Find a Location
Who is running the clinical trial?
University of IowaOTHER
446 Previous Clinical Trials
879,472 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
124 Patients Enrolled for Cystic Fibrosis
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,964 Total Patients Enrolled
Tahuanty Pena, MDPrincipal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any worsening of my condition in the last 28 days.I have changed my lung treatment plan within the last 28 days.I have been on Elexacaftor-Tezacaftor-Ivacaftor for over 90 days.I am willing to do airway clearance exercises twice a day for 3 to 6 months.I am older than 18 years.I am currently being treated for a lung infection not caused by tuberculosis.I cannot tolerate treatments to clear my airways.You are currently smoking cigarettes, using e-cigarettes, or smoking marijuana or other recreational drugs.You are currently using an experimental medication.I am currently being treated for a sudden worsening of lung symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous
- Group 2: Symptom driven
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective of this experiment?
"During this 12-week trial, the primary outcome evaluated will be Absolute change in percent predicted FEV1 (ppFEV1) from week 0 to week 12. Secondary outcomes include: a difference between symptom driven airway clearance arm and continue daily airway clearance arm in the absolute change of respiratory symptoms based upon Cystic fibrosis Questionnaire Revise score; an absolute difference in sputum/throat cultures positive for S. aureus or P. aeruginosa; and proportion of participants with at least one event per week to determine Incidence of adverse events (AE)."
Answered by AI
Are there any remaining vacancies in this clinical experiment?
"As verified on clinicaltrials.gov, recruitment for this trial has ended; it was first posted in January 1st 2023 and last updated on May 27th 2022. Nonetheless, 413 other studies are still actively recruiting patients at present."
Answered by AI
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