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Corticosteroid

Inhaled Steroids/Long-Acting Bronchodilators for Asthma

Q: What medical issues does this therapy commonly address?

This medication can help alleviate allergies to mold, as well as sinusitis, vasomotor rhinitis, and acute coryza.

Q: Is this therapy considered to be risk-free for those who are treated?

This treatment has demonstrated sufficient safety and efficacy, receiving a score of 3 on our scale. This is because the drug is in Phase 4 clinical trials, meaning it is approved for use.

Q: What is the uppermost capacity for enrollment into this exploration?

Affirmative. The information on clinicaltrials.gov affirms that this research project, which was first published on October 1st 2007, is actively enrolling individuals. A total of 50 participants must be recruited from a single site.

Q: Is enrollment open at this time for the clinical trial?

According to clinicaltrials.gov, this medical trial is actively searching for volunteers and has been doing so since October 1st 2007 when it was first posted; the most recent update being on July 26th 2020.

Q: Is the eligibility for this research limited to those below 30 years of age?

As stipulated by the research protocol, prospective participants need to be between 10 and 80 years old.

Q: Are there any other studies demonstrating the effectiveness of this treatment method?

Presently, there are 48 trials investigating the efficacy of this treatment. Of those active clinical studies, 16 have progressed to Phase 3. Research sites for this particular medication are mainly based in Ann Arbor but span 1291 locations globally.

Q: Can I be a participant in this medical study?

This research is recruiting 50 participants aged between 10 and 80 years old that have a current <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a> diagnosis. Furthermore, these patients must not be smokers with less than 10 pack-year <a href="https://www.withpower.com/clinical-trials/smoking">smoking</a> history.

Phase 4

Recruiting

Led By Arthur F Gelb, MD

Research Sponsored by Gelb, Arthur F., M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-80 yr

Post 180ug albuterol by MDI: FEV 1/FVC < 70% and FEV 1 <80% predicted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-5 years

Awards & highlights

Study Summary

This trial is looking at the different sites and causes of airflow limitation in asthmatics, and whether certain treatments can help.

Who is the study for?

This trial is for stable, treated asthmatics aged 10-80 who are current non-smokers with a minimal smoking history. Participants should have specific levels of lung function reduction after using albuterol. Pregnant individuals cannot participate.Check my eligibility

What is being tested?

The study tests the effects of two inhaled treatments: budesonide/formoterol and fluticasone/salmeterol on airflow limitation in asthma patients. It aims to identify which airways are affected and how inflammation can be reduced using different doses.See study design

What are the potential side effects?

Possible side effects include throat irritation, hoarseness, coughing, headaches, and an increased risk of infections due to the suppression of immune responses in the airways by corticosteroids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 80 years old.

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My lung function tests show severe asthma or COPD.

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I currently do not smoke and have smoked less than 10 pack-years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Exhaled nitric oxide

Secondary outcome measures

Mechanism(s) of expiratory airflow limitation

Presence of unsuspected emphysema by autopsy or explanted lung

Trial Design

1Treatment groups

Experimental Treatment

Group I: Asthma observational study armExperimental Treatment2 Interventions

Asthmatics in this arm may be on varying dose of inhaled fluticasone 100-500mcg/salmeterol 50mcg bid via Advair MDI or equivalent dose via Diskus bid or Symbicort (budesonide 80-160mcg/formoterol 4.5mcg bid)or Dulera 100-200mcg mometasone/5 mcg formoterol bid, tiotropium 18mcg capsule daily. This is an observational study and additional pharmacologic intervention may include antibiotic and tapering doses of corticosteroids.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gelb, Arthur F., M.D.Lead Sponsor

6 Previous Clinical Trials

298 Total Patients Enrolled

3 Trials studying Asthma

139 Patients Enrolled for Asthma

Arthur F Gelb, MDPrincipal Investigator - Arthur F Gelb Medical Corporation

Arthur F Gelb Medical Corporation, Lakewood Regional Medical Center, Long Beach Memorial Medical Center

St Louis University School Of Medicine (Medical School)

Moffitt Hosp University Of California (Residency)

5 Previous Clinical Trials

218 Total Patients Enrolled

2 Trials studying Asthma

120 Patients Enrolled for Asthma

Media Library

Budesonide/Formoterol (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT01225913 — Phase 4

Asthma Research Study Groups: Asthma observational study arm

Asthma Clinical Trial 2023: Budesonide/Formoterol Highlights & Side Effects. Trial Name: NCT01225913 — Phase 4

Budesonide/Formoterol (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01225913 — Phase 4

Frequently Asked Questions

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

What medical issues does this therapy commonly address?

"This medication can help alleviate allergies to mold, as well as sinusitis, vasomotor rhinitis, and acute coryza."

Answered by AI

Is this therapy considered to be risk-free for those who are treated?

"This treatment has demonstrated sufficient safety and efficacy, receiving a score of 3 on our scale. This is because the drug is in Phase 4 clinical trials, meaning it is approved for use."

Answered by AI

What is the uppermost capacity for enrollment into this exploration?

"Affirmative. The information on clinicaltrials.gov affirms that this research project, which was first published on October 1st 2007, is actively enrolling individuals. A total of 50 participants must be recruited from a single site."

Answered by AI

Is enrollment open at this time for the clinical trial?

"According to clinicaltrials.gov, this medical trial is actively searching for volunteers and has been doing so since October 1st 2007 when it was first posted; the most recent update being on July 26th 2020."

Answered by AI

Is the eligibility for this research limited to those below 30 years of age?

"As stipulated by the research protocol, prospective participants need to be between 10 and 80 years old."

Answered by AI

Are there any other studies demonstrating the effectiveness of this treatment method?

"Presently, there are 48 trials investigating the efficacy of this treatment. Of those active clinical studies, 16 have progressed to Phase 3. Research sites for this particular medication are mainly based in Ann Arbor but span 1291 locations globally."

Answered by AI

Can I be a participant in this medical study?

"This research is recruiting 50 participants aged between 10 and 80 years old that have a current asthma diagnosis. Furthermore, these patients must not be smokers with less than 10 pack-year smoking history."

Answered by AI