Asthma control study: comparing two inhalers over 12 weeks

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    What is this study about?

    This study compares two inhalers for asthma control over 12 weeks. One combines budesonide and formoterol fumarate, and the other contains only budesonide. Around 340 adults and teens with poorly controlled asthma despite current treatment will participate. The study measures lung function, asthma symptoms, and medication safety. It’s a double-blind trial, meaning neither participants nor researchers know who receives which inhaler.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Jindrichuv Hradec , Czechia

      Louny , Czechia

      Lovosice , Czechia

      Miroslav , Czechia

      Praha 11 , Czechia

      Praha 9 , Czechia

      Teplice , Czechia

      Varnsdorf , Czechia

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The patient steps involved in this clinical trial are as follows:

      1. The trial is a 12-week study where participants will either receive the Budesonide and Formoterol Fumarate Metered Dose Inhaler (BFF MDI) 160/9.6 µg twice daily or the Budesonide Metered Dose Inhaler (BD MDI) 160 µg twice daily.
      2. Participants in the study will consist of adult and adolescent patients with asthma who remain inadequately controlled, as demonstrated by an Asthma Control Questionnaire (ACQ)-7 total score ≥1.5, despite treatment with a low dose inhaled corticosteroid (ICS) or ICS plus long-acting beta2-agonist (LABA).
      3. Throughout the study, the efficacy and safety of BFF MDI on lung function and asthma health-related quality of life will be assessed.

      This information describes the medication regimen for the trial and the general profile of participants but does not include all the procedural steps a participant will undergo during the trial. For a full understanding of all the steps, including visits to the study site, tests, and assessments, more detailed information from the trial documents would be needed.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a documented history of physician-diagnosed asthma for at least 6 months prior to Visit 1, according to GINA guidelines.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria, along with explanations of medical terms where necessary:

      Inclusion Criteria:

      1. Age between 12 to 80 years, applies to both males and females. Body Mass Index (BMI) must be less than 40 kg/m². Females of childbearing potential should be using highly effective birth control.
      2. Documented history of physician-diagnosed asthma for at least 6 months prior to Visit 1, according to GINA guidelines. GINA stands for Global Initiative for Asthma, which provides standards for asthma diagnosis and management. Adolescent participants (12 to < 18 years of age) must provide healthcare records for one year prior to Visit 1.
      3. Regular use of a stable daily inhaled corticosteroid (ICS) or ICS with a long-acting beta-agonist (LABA) regimen (including a stable ICS dose) for at least 8 weeks prior to Visit 1. ICS are medications used to control and prevent asthma symptoms, and LABA is a type of medication that helps to keep airway muscles relaxed.
      4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4. The ACQ-7 score measures the control of asthma symptoms. It has seven questions, and a score of 1.5 or above suggests poor asthma control.
      5. A pre-bronchodilator/pre-dose Forced Expiratory Volume in 1 Second (FEV1) < 90% of the predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization). FEV1 is a measure of lung function that indicates the amount of air a person can forcefully exhale in one second.
      6. Reversibility to albuterol, defined as an increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age or a ≥ 12% increase for participants aged 12 to < 18 years either in the 12 months prior to Visit 1 or at Visit 2 or 3 if repeat testing is necessary. Albuterol is a medication that opens up the airways in the lungs, and this reversibility test measures improvement in lung function after taking albuterol, indicating responsiveness of airways to treatment.
      7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that has not changed more than 20% (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit.
      8. Asthma stability during the run-in period based on the investigator’s discretion using a symptom worsening assessment as a guideline.
      9. The willingness and ability, in the opinion of the investigator, to adjust current asthma therapy as required by the protocol.
      10. Demonstrated acceptable Metered-Dose Inhaler (MDI) administration technique. An MDI is a device that delivers a specific amount of medication to the lungs in the form of a short burst of aerosolized medicine.
      11. eDiary compliance ≥ 70% during screening, which means completing the daily electronic diary and responding “Yes” to taking two puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria for Clinical Trial Participation:

      1. Life-threatening asthma: This includes a history of severe asthma attacks requiring intubation due to high blood levels of carbon dioxide (hypercapnia), respiratory arrest, seizures caused by a lack of oxygen (hypoxic seizures), or fainting episodes (asthma related syncope).
      2. Recent respiratory infection or asthma exacerbation: Treatment with systemic corticosteroids and/or increased dosage of inhaled corticosteroids (ICS) within the past 8 weeks before your first visit to the study site and throughout the screening period.
      3. Hospitalization for asthma: If you have been hospitalized for asthma within 8 weeks prior to the first study visit.
      4. Clinically significant diseases: Any current or historical evidence of serious diseases, including but not limited to heart, liver, kidney, blood, neurological, hormonal, stomach, or lung diseases. Examples include active tuberculosis, abnormal widening of the airways (bronchiectasis), lung diseases characterized by high white blood cell counts (pulmonary eosinophilic syndromes), and chronic obstructive pulmonary disease (COPD).
      5. Drug or alcohol abuse: A known history of substance abuse within the last 12 months.
      6. Cancer: If you have cancer that is not surgically removable and has not been in complete remission for at least 5 years (excluding certain skin cancers).
      7. Participation in other clinical studies: If you have received a study intervention within the last 30 days or 5 half-lives of the drug, whichever is longer. Other than this clinical study, you cannot participate in any additional studies using unapproved medications.
      8. Prior participation in specific studies: If you have been part of previous studies within the AEROSPHERE program or have been treated with glycopyrronium.
      9. Nebulizer use: Regular use of a nebulizer or home nebulizer system for asthma medication, except for temporary use during hospitalization for an asthma attack, provided there’s no occurrence within 8 weeks of Visit 1.
      10. Stable medication dosing: If you have not met the required stable dosing period for your asthma medications before Visit 1 or if you are unable to avoid medications not permitted by the study during the screening and treatment periods.
      11. Recent COVID-19 vaccination: If you have received a COVID-19 vaccine within 7 days before Visit 1.
      12. Allergy to study drugs: Known hypersensitivity to beta2-agonists, corticosteroids, or any component of the metered-dose inhaler (MDI) used in the study.
      13. Clinically relevant abnormal findings: Any physical examination, blood test, vital sign, or electrocardiogram (ECG) abnormality that could put your safety at risk or affect the study.
      14. Tobacco or marijuana use: If you are a current smoker, a former smoker with a smoking history of more than 10 pack-years, or you quit smoking less than 6 months before Visit 1.
      15. Planned hospitalization: If you are planning to be hospitalized during the study period.
      16. Study staff or family involvement: If you or your immediate family members are involved in the planning or conduct of the study or are employees at the study site.
      17. Investigator’s concern about compliance: If the Investigator judges that you are unlikely to follow the study’s procedures, restrictions, and requirements.
      18. Pregnancy, breast-feeding, or lack of birth control: For women, being currently pregnant, breastfeeding, planning a pregnancy during the study period, or not using effective contraception as judged by the Investigator.

      Please let me know if you need more detailed explanations on any of the terms above.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Budesonide/Formoterol Fumarate (BFF): This metered-dose inhaler (MDI) combines budesonide, a corticosteroid that reduces inflammation in the airways, with formoterol fumarate, a long-acting beta2-agonist that helps to relax muscles in the airways to improve breathing. The combination is used in the dosage of 160/9.6 µg twice daily (BID), amounting to a total daily dosage of 320/19.2 µg.
      2. Budesonide (BD): This metered-dose inhaler contains budesonide alone, without the long-acting beta2-agonist. Budesonide is used to decrease inflammation in the lungs and is used in the dosage of 160 µg twice daily (BID), totaling 320 µg per day.

      These drugs are being studied for their efficacy and safety in adults and adolescents with inadequately controlled asthma.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Yes, the active substances participating in this clinical trial are already known to medicine and the medical literature:

      • Budesonide – Budesonide is a well-established inhaled corticosteroid used in the treatment of asthma and other respiratory conditions. It has anti-inflammatory effects in the airways.
      • Formoterol fumarate – Formoterol is a long-acting beta2-agonist (LABA) bronchodilator that is commonly used in combination with inhaled corticosteroids like budesonide to provide long-term control of asthma symptoms. It relaxes the muscles of the airways to improve breathing.

      Both of these medications have been extensively studied and are widely used in clinical practice for the management of asthma. The combination of an inhaled corticosteroid and LABA is a standard treatment approach for patients whose asthma is not adequately controlled with an inhaled corticosteroid alone.


      Study ID

      CT-EU-00029872

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Diseases