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NCT06067828RECRUITINGIRB Ready

A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

(ATHLOS)

Sponsored by AstraZeneca

Quick Self-Assessment

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Preparing your pre-screening questions...
๐Ÿ“Š
1 of 180 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

Who Can Participate

Inclusion Criteria

Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
Participant must have:
a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) \< 0.7 at Visit 1
a post-bronchodilator FEV1 โ‰ฅ 30% and \<80% predicted normal (moderate to severe COPD) at Visit 1.
a score of โ‰ฅ 2 on the modified Medical Research Council at Visit 1.
pre-bronchodilator FRC of \> 120% of predicted normal FRC values at Visit 1.
a constant work rate test endurance time of 3 to 8 minutes at Visit 2.
Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
Current or former smoker with a history of โ‰ฅ 10 pack-years of tobacco smoking
Body mass index \< 40 kg/m2.
Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

180 participants

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Age Range

40 Years - 80 Years

โšง

Gender

ALL

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Sponsor

AstraZeneca

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Los Angeles

California

Location available
View Los Angeles location page
Unknown

Tarzana

California

Location available
View Tarzana location page
Unknown

Torrance

California

Location available
View Torrance location page
Unknown

Brooksville

Florida

Location available
View Brooksville location page
Unknown

Anderson

South Carolina

Location available
View Anderson location page
Unknown

Greenville

South Carolina

Location available
View Greenville location page
Unknown

Spartanburg

South Carolina

Location available
View Spartanburg location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for COPD Treatment in Los Angeles?

Join others in California exploring innovative treatment options through clinical research

COPD Treatment Options in Los Angeles, California

If you're searching for COPD treatment in Los Angeles, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Los Angeles, Tarzana, Torrance and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with COPD. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 180 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for COPD?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for COPD

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This COPD Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06067828. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.