Persistent AsthmaPhase 4NCT04271839
Efficiency Control of Fluticasone/Formoterol K-haler (Medium Strength) vs ICS/LABA (High Strength) in Asthma Patients
A Phase 4 study testing fluticasone/formoterol k-haler (medium strength) in people with Persistent Asthma, run by Mundipharma Pharmaceuticals S.L..
Trial summary
Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Asthma
- What is being tested?
- fluticasone/formoterol k-haler (medium strength)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2020to May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years.
- Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma)
- Patients in treatment with a stable average dose of IC in a fixed dose combination of IC / LABA *, without changes in the dose or in the inhaler, during the 3 months prior to inclusion, in accordance with its approved indication and Data sheet. * Except for K-Haler®
- Patients who need, according to medical criteria, a dose increase of IC in the current fixed IC / LABA combination.
- Inhalation technique: no critical errors with the current inhaler after training.
- Patient with uncontrolled asthma with an ACQ> 0.75 points (partially controlled or poorly controlled asthma).
- Informed consent in signed writing.
Who cannot join
- Diagnosis of other respiratory pathology other than asthma (clinically relevant bronchiectasis, pulmonary fibrosis, COPD (Chronic Obstructive Pulmonary Disease) and others at the discretion of the investigator).
- ≥1 severe exacerbation (require the use of systemic corticosteroids - oral, suspension or injection - or increasing the dose of maintenance therapy for at least 3 days, or hospitalization or emergency room visits due to asthma requiring the use of systemic corticosteroids) in the last month or ≥3 in the previous 12 months.
- Pregnancy or probability of being pregnant during the study.
- Patient who, at the discretion of the investigator, does not have the capacity to complete the questionnaires.
- Patient under treatment with monoclonal antibodies during the study.
- Patient in another clinical trial.
Show all 13Show fewer
- Patient who has received an experimental drug in the last 30 days (12 weeks if it is a systemic steroid).
- Do not use a MART (MAintenance and Reliever Therapy) strategy within 3 months prior to inclusion or during the trial
- Patient in IC / LABA treatment according to MART strategy (Maintenance and Rescue).
- Any contraindication expressed in the CI / LABA data sheet used.
- Patient with poor adherence (TAI-10 ≤ 45)
- Patients using an inhalation chamber
- Patients with an index of Packages / year> 10
About this study
Official title: Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatment of Patients With Persistent Asthma
Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.
Read the detailed description
Asthma is a common chronic respiratory disease that affects about 300 million people worldwide. Although knowledge about asthma and its treatment has improved over the past decade, morbidity and mortality remain considerable.
Inhaled therapy is the treatment of choice in persistent asthma. Lower doses of drug are used that maximize the therapeutic effect and minimize side effects.
Inhaled therapy is administered primarily through inhalers. The goal is to deliver the maximum amount of medication to your therapeutic target in the lungs → lung deposit Each inhaler offers a different lung deposit figure (data in ideal conditions). However, asthma control also depends on other factors (inhalation technique, adhesion, asthma severity, drug dose, etc.).
The K-haler® inhaler device has obtained a high lung deposit (≈45% of the emitted dose) and an easy-to-use device.
In general, the rest of the CI / LABA inhalers offer lower deposit figures. They are between ≈10-40% of the dose.
Taking into account all that has been said in the introduction section, it has been decided to design this low-intervention clinical trial, to verify whether, those technical benefits of K-haler®, control asthma in a similar way using lower doses of IC .
If these hypotheses were confirmed, it would allow for an effective therapeutic option in the control of asthma using a lower therapeutic dose, saving IC and a lower probability of producing side effects.
Demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.
- Conditions
- Persistent Asthma
- Being tested
- fluticasone/formoterol k-haler (medium strength), Standard of care (ICs/LABA high strength)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone/formoterol k-haler (medium strength)Combination product
Also called No other interventions
2 inhalations every 12 hours
Standard of care (ICs/LABA high strength)Combination product
Also called No other interventions
Depend of the ICs/LABA combination
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone/formoterol k-haler (medium strength) | Experimental | In this arm, uncontrolled patients who arrive at the consultation with their fixed combination of ICs (Inhaled CorticosteroidS) / LABA (Long-Acting Beta2-Agonist) (medium strength) will change their treatment to Fluticasone / formoterol k-haler (medium strength) Receives: Combination Product: fluticasone/formoterol k-haler (medium strength) |
| Standard of Care (SoC) | Active comparator | In this arm, uncontrolled patients arriving at the consultation with their fixed combination of ICs / LABA (medium strength) will change their treatment to the same fixed combination of ICs / LABA (high strength) Receives: Combination Product: Standard of care (ICs/LABA high strength) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of asthma
The control of asthma in patients with persistent asthma will be measured by scoring the ACQ-7 questionnaire (Asthma Control Questionnaire): Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:> 1.50
Measured: 24 weeks
Secondary outcomes (11)
Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions
Well Controlled (negative answer in the 4 questions), Partially controlled (affirmative answer in 1 or 2 of the answers), Uncontrolled (affirmative answer in 3 or 4 of the answers)
Measured: 24 weeks
Success in asthma treatment
Defined as asthma patients who progress from poorly controlled asthma to partially or well controlled asthma, or from partially controlled asthma to controlled asthma, with no change in baseline asthma treatment after randomization
Measured by scoring the ACQ-7 questionnaire: Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:> 1.50
Measured: 24 weeks
Adherence to treatment
Through TAI-12 questionnaire (Erratic Total Score 1-5 items, Deliberate Total Score 6-10 items, Unconscious Total Score 11-12 items) And through electronic prescription (if the amount of medication withdrawn in pharmacy matches that prescribed by the doctor)
Measured: 24 weeks
Critical errors with the inhaler
Number of critical errors
Measured: 24 weeks
Patient satisfaction with the inhaler
Through the FSI-10 (Feeling of Satisfaction with Inhaler) questionnaire (It consists of 10 questions, each with 5 response options on a 5-step Likert scale ("a lot", "a lot", "something", "little" and "very little") scored, respectively, from 5 to 1 (score total: 50). It evaluates the degree of patient satisfaction with the inhalation device and includes items related to comfort, difficulty, transportability and use.)
Measured: 24 weeks
Quality of Life of the patient
Through Mini-AQLQ (Mini Asthma Quality of Life Questionnaire) questionnaire: This 15-item questionnaire is a short version of the complete 32-item questionnaire, but constitutes of the same 4 domains: symptoms, environment, emotions, activities, and covering a 2 week period. Scores range from 0-6 (lower is worse). The mini-AQLQ score is calculated as the average of domain items. The minimum clinically important difference is 0.5.
This version has been developed to meet the needs of long-term monitoring, where efficiency may take precedent over precision of measurement
Measured: 24 weeks
Severe asthmatic exacerbations
Number severe asthmatic exacerbations (require the use of systemic corticosteroids - oral, suspension or injection - or the increase in the dose of maintenance therapy for at least 3 days, or hospitalization or visits to the emergency room due to asthma that requires the use of systemic corticosteroids)
Measured: 24 weeks
Forced Expiratory Volume at first second (FEV1)
Using the FEV1 score of the patient's spirometry
Measured: 24 weeks
Forced Vital Capacity (FVC)
Using the FVC score of the patient's spirometry
Measured: 24 weeks
FEV1 / FVC ratio
Using the FEV1 and FVC score of the patient's spirometry
Measured: 24 weeks
Safety of the drug in investigation.
Type and incidence of adverse reactions
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start11 Jun 2020
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: The trial has been terminated early due to the SARS-CoV-2 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Pharmaceuticals S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alpha Bioresearch S.L., Dynamic Solutions
- Responsible party
- Principal investigator, Rubén Lesmes Escudero, Mundipharma Pharmaceuticals S.L.
- Investigators
- José Luis Velasco Garrido, MD, Study director, Hospital Virgen de la VictoriaJavier Domínguez Ortega, MD, Study director, Hospital La PazPatricia García Sidro, MD, Principal investigator, Hospital La planaErnesto Enrique Miranda, MD, Principal investigator, Hospital General de CastellónAna Gómez-Bastero Fernández, MD, Principal investigator, Hospital Universitario Virgen MacarenaAlicia Padilla Galo, MD, Principal investigator, Hospital Costa del SolFernando Florido López, MD, Principal investigator, Hospital San CecilioJoaquín Quiralte Enriquez, MD, Principal investigator, Hospital Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271839
- Sponsor's protocol ID
- EffICIENCY
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatment of Patients With Persistent Asthma
- ClinicalTrials.gov ID
- NCT04271839
- Acronym / sponsor ID
- EffICIENCY
- Conditions
- Persistent Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial has been terminated early due to the SARS-CoV-2 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mundipharma Pharmaceuticals S.L.Industry (pharma, biotech, devices)
- Collaborators
- Alpha Bioresearch S.L., Dynamic Solutions
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.
Detailed description
Asthma is a common chronic respiratory disease that affects about 300 million people worldwide. Although knowledge about asthma and its treatment has improved over the past decade, morbidity and mortality remain considerable.
Inhaled therapy is the treatment of choice in persistent asthma. Lower doses of drug are used that maximize the therapeutic effect and minimize side effects.
Inhaled therapy is administered primarily through inhalers. The goal is to deliver the maximum amount of medication to your therapeutic target in the lungs → lung deposit Each inhaler offers a different lung deposit figure (data in ideal conditions). However, asthma control also depends on other factors (inhalation technique, adhesion, asthma severity, drug dose, etc.).
The K-haler® inhaler device has obtained a high lung deposit (≈45% of the emitted dose) and an easy-to-use device.
In general, the rest of the CI / LABA inhalers offer lower deposit figures. They are between ≈10-40% of the dose.
Taking into account all that has been said in the introduction section, it has been decided to design this low-intervention clinical trial, to verify whether, those technical benefits of K-haler®, control asthma in a similar way using lower doses of IC .
If these hypotheses were confirmed, it would allow for an effective therapeutic option in the control of asthma using a lower therapeutic dose, saving IC and a lower probability of producing side effects.
Demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone/formoterol k-haler (medium strength) | Experimental | Combination Product: fluticasone/formoterol k-haler (medium strength)In this arm, uncontrolled patients who arrive at the consultation with their fixed combination of ICs (Inhaled CorticosteroidS) / LABA (Long-Acting Beta2-Agonist) (medium strength) will change their treatment to Fluticasone / formoterol k-haler (medium strength) |
| Standard of Care (SoC) | Active comparator | Combination Product: Standard of care (ICs/LABA high strength)In this arm, uncontrolled patients arriving at the consultation with their fixed combination of ICs / LABA (medium strength) will change their treatment to the same fixed combination of ICs / LABA (high strength) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > or = 18 years.
- Objective diagnosis of asthma (according to GEMA 4.4) (Guía Española de Manejo del Asma)
- Patients in treatment with a stable average dose of IC in a fixed dose combination of IC / LABA *, without changes in the dose or in the inhaler, during the 3 months prior to inclusion, in accordance with its approved indication and Data sheet. * Except for K-Haler®
- Patients who need, according to medical criteria, a dose increase of IC in the current fixed IC / LABA combination.
- Inhalation technique: no critical errors with the current inhaler after training.
Key exclusion criteria (13 listed)
- Diagnosis of other respiratory pathology other than asthma (clinically relevant bronchiectasis, pulmonary fibrosis, COPD (Chronic Obstructive Pulmonary Disease) and others at the discretion of the investigator).
- ≥1 severe exacerbation (require the use of systemic corticosteroids - oral, suspension or injection - or increasing the dose of maintenance therapy for at least 3 days, or hospitalization or emergency room visits due to asthma requiring the use of systemic corticosteroids) in the last month or ≥3 in the previous 12 months.
- Pregnancy or probability of being pregnant during the study.
- Patient who, at the discretion of the investigator, does not have the capacity to complete the questionnaires.
- Patient under treatment with monoclonal antibodies during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone/formoterol k-haler (medium strength)Also: No other interventions2 inhalations every 12 hours | Combination product | Fluticasone/formoterol k-haler (medium strength) |
| Standard of care (ICs/LABA high strength)Also: No other interventionsDepend of the ICs/LABA combination | Combination product | Standard of Care (SoC) |
Primary outcome
Control of asthma
Time frame: 24 weeks
The control of asthma in patients with persistent asthma will be measured by scoring the ACQ-7 questionnaire (Asthma Control Questionnaire): Well controlled: ≤ 0.75, Partially controlled: from 0.75 to 1.50, Poorly controlled:> 1.50
11 secondary outcomes
Degree of asthma control according to GINA (Global Initiative for Asthma) questionnaire of four questions
Time frame: 24 weeks
Success in asthma treatment
Time frame: 24 weeks
Adherence to treatment
Time frame: 24 weeks
Critical errors with the inhaler
Time frame: 24 weeks
Patient satisfaction with the inhaler
Time frame: 24 weeks
Quality of Life of the patient
Time frame: 24 weeks
Severe asthmatic exacerbations
Time frame: 24 weeks
Forced Expiratory Volume at first second (FEV1)
Time frame: 24 weeks
Forced Vital Capacity (FVC)
Time frame: 24 weeks
FEV1 / FVC ratio
Time frame: 24 weeks
Safety of the drug in investigation.
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Related trials for Persistent Asthma
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Not yet recruitingPhase 1
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Asthma (Diagnosis), Persistent Asthma
Not yet recruiting
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Asthma, Asthma Chronic
RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Allergic Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Luis Velasco Garrido, MD study director
Hospital Virgen de la Victoria
Javier Domínguez Ortega, MD study director
Hospital La Paz
Patricia García Sidro, MD principal investigator
Hospital La plana
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone/formoterol k-haler (medium strength) in people with Persistent Asthma, run by Mundipharma Pharmaceuticals S.L..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of asthma (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.