AsthmaPMC-101-APTNCT02757209
Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD
A study testing Spiromax (budesonide/formoterol), Turbohaler (budesonide/formoterol) and Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) in people with Asthma and COPD, run by Consorzio Futuro in Ricerca at 3 sites in Italy.
Trial summary
This is a randomized, multi-center, active-controlled, repeated measures design study in male and female patients 60 years of age and older with persistent asthma or COPD. Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano delle Murge (Ba), Tradate. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Spiromax (budesonide/formoterol), Turbohaler (budesonide/formoterol) and Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesItaly
- Study dates
- Apr 2016to Jan 2018
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent. Written informed consent/assent signed and dated by the patient before conducting any study related procedure.
- Age. Male or female patients 60 years and older as of the Screening Visit (SV)
- Asthma or COPD diagnosis. Previous or new Asthma/COPD diagnosis in accordance with the Global Initiative for Asthma (GINA) or Global initiative for chronic Obstructive Lung Disease (GOLD).
- Severity of respiratory disease: Persistent asthma, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months duration. COPD, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months.
- Stable state. Patients without exacerbations and without change in the previous treatment for at least 4 weeks prior to the visit 1 as defined by clinical history.
- Comorbidities. No concomitant severe comorbidities which could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study observations/results, or put the patient at increased risk during the study.
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- Current Therapy: Patients needing combination ICS/LABA already in treatment with PDI (Turbohaler) or Diskus.
- Short-Acting beta2-Agonists: All patients must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at the visit 1 for use as needed for the duration of the study.
- Patients must be able to withhold all inhaled short-acting betapathomimetic bronchodilators for at least 6 hours prior to all study visits.
- Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc.).
Who cannot join
- Asthma severity. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- COPD severity. COPD with a pre-bronchodilator FEV1 < 30% and/or FEV1 30-50% but requiring long term oxygen therapy.
- Exacerbations. Any asthma/COPD exacerbation within one month of the visit 1. A patient must not have had any hospitalisation for asthma/COPD within 6 months prior to the visit 1.
- Respiratory infections. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the visit 1.
- Comorbidities. Historical or current evidence of a clinically significant comorbidity including, but not limited to: cardiovascular (e.g. congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological (e.g. immunologic compromise), neuropsychological, endocrine (e.g. uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g. poorly-controlled peptic ulcer, gastroesophageal reflux disease), pulmonary (e.g. bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, lung cancer) or history of a positive test for HIV, hepatitis B or hepatitis C infection. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
- History of any adverse reaction. History of any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the inhalers used in the study (e.g. lactose in the dry powder inhalers).
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- Use of immunosuppressive medications. Use of immunosuppressive medications within 12 weeks prior visit 1 and during the study, including use of systemic corticosteroids. Immunotherapy at a stable dose for at least 90 days prior to the visit 1 and throughout the study for the treatment of allergies is permitted.
- Smoking. Current smokers are excluded. A patient may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
- Concomitant participation to other research study. Participation to another research study investigational drug study within the 30 days (starting at the final follow-up visit) preceding the visit 1 or planned participation in another investigational drug study at any time during this study.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
3) Fondazione S. Maugeri - IRCCS - Dipartimento di Pneumologia Riabilitativa
Cassano delle Murge, Bari, 70020
University Hospital S Anna
Ferrara, Fe, 44124
4) Clinica di Malattie dall'Apparato Respiratorio Fondazione Salvatore Maugeri
Tradate, Varese, 21049
About this study
Official title: STUDY NUMBER: PMC-101-APT Usability and Adherence of Spiromax® Inhaler Device, Turbohaler® and Diskus® Inhaler Devices for Fixed Combination of Corticosteroid/Long-acting beta2- Agonist, in Adults With Asthma or COPD
This is a randomized, multi-center, active-controlled, repeated measures design study in male and female patients 60 years of age and older with persistent asthma or COPD.
Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano delle Murge (Ba), Tradate.
The primary efficacy parameter of the study is inhaler device usability (expressed as total number of repeated attempts required to achieve optimal use).
Read the detailed description
Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common conditions with an increasing prevalence worldwide. Inhaled therapy for these conditions has a number of advantages over systemic therapy, including reduced side effects and quicker onset of action.
However, poor asthma control is common, despite available effective treatment .This is partially related to low adherence and to difficulties in using inhaler devices. Among patients with chronic respiratory disorders, 18% discontinued the prescribed inhaler treatment because of troubles with the device (Santus 2012). Some devices are not easy to handle, or require breathing abilities, which reduce the effectiveness in real life, especially in elderly.Since mistakes in inhaler technique are very common affecting drug delivery and efficacy, a correct inhaler technique training is fundamental. A single site study in 2012 (Press 2012) found that patients given verbal and written instructions followed by demonstrations of inhaler use had better inhaler technique than patients given verbal and written instructions only. The authors concluded that larger multi-centred studies were needed to evaluate hospital-based-education.
Proposals to improve inhalers use are based on three key points:
- the choice of the best device paying attention to patient needs and abilities (personalized therapy)
- a complete explanation of the correct use (patient training)
- a regular re-check to evaluate the maintenance of a correct technique (monitoring)
The study consists of two phases:
- A cross over phase: 3 periods of 1 week each. During the training visit at the beginning of each week period, patients will be instructed on the correct use of one of the 3 devices. Correct use and maintenance of correct use after 1 week will be assessed.
- A longitudinal phase: patient will be treated with the last inhaler device used during the cross over phase for 8 additional weeks.
The maximum time from screening to end of study visit is12 weeks, with a follow up taking place 30 days after the final visit .
- Being tested
- Spiromax (budesonide/formoterol), Turbohaler (budesonide/formoterol), Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)
- Keywords
- ASTHMA, COPD, budesonide, formoterol, Salmeterol, Fluticasone, Spiromax, DPI, Diskus
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiromax (budesonide/formoterol)Device
DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week.
Additional 8 weeks in one subgroup
Turbohaler (budesonide/formoterol)Device
Turbohaler® (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate)- Symbicort® 160/4.5. Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup
Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)Device
Diskus® inhaler(50mcg salmeterol\&250/500mcg fluticasone propionate)-Seretide Diskus 50/250mcg® or 50/500mcg.Dose of 1inhalation twice a day for1 week.Additional 8 weeks in1subgroup
| Study group | Role | What they receive |
|---|---|---|
| Spiromax Inhaler | Active comparator | Evaluation of correct use of Spiromax inhaler - DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week.
Additional 8 weeks in one subgroup Receives: Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) |
| Turbohaler inhaler | Active comparator | Turbohaler® - Symbicort® 160/4.5 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate). Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week.
Additional 8 weeks in one subgroup Receives: Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) |
| Diskus Inhaler | Active comparator | Diskus® inhaler - Seretide Diskus 50/250 mcg ® or 50/500 mcg (50 mcg salmeterol \& 250/500 mcg fluticasone propionate). Dose of one inhalation twice a day for 1 week.
Additional 8 weeks in one subgroup Receives: Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Spiromax , Turbuhaler and Diskus devices
number of attemps required to acheive optimal use
Measured: day 1
Secondary outcomes (3)
Short term maintenance of correct use
Ease of use: Number of errors after 1 week use
Measured: 1 weeks of treatment (cross sectional phase)
Long term maintenance of correct use
number of errors after 8 additional weeks of use
Measured: 8 weeks of treatment at the end of the longitudinal phase
Patient's preference for different devices
Patient's preference for different devices b using PAPSQ questionnaire and VAS scales
Measured: 8 weeks of treatment at the end of the longitudinal phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Futuro in Ricerca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto Papi, MD, Study chair, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757209
- Sponsor's protocol ID
- PMC-101-APT
- Acronym
- PMC-101-APT
- Status last verified
- Jan 2018
- First submitted
- 4 Apr 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY NUMBER: PMC-101-APT Usability and Adherence of Spiromax® Inhaler Device, Turbohaler® and Diskus® Inhaler Devices for Fixed Combination of Corticosteroid/Long-acting beta2- Agonist, in Adults With Asthma or COPD
- ClinicalTrials.gov ID
- NCT02757209
- Acronym / sponsor ID
- PMC-101-APT / PMC-101-APT
- Keywords
- ASTHMA, COPD, budesonide, formoterol, Salmeterol, Fluticasone, Spiromax, DPI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Consorzio Futuro in RicercaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 2 May 2016 (estimated)
- 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.
This is a randomized, multi-center, active-controlled, repeated measures design study in male and female patients 60 years of age and older with persistent asthma or COPD.
Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano delle Murge (Ba), Tradate.
The primary efficacy parameter of the study is inhaler device usability (expressed as total number of repeated attempts required to achieve optimal use).
Detailed description
Asthma and Chronic Obstructive Pulmonary Disease (COPD) are common conditions with an increasing prevalence worldwide. Inhaled therapy for these conditions has a number of advantages over systemic therapy, including reduced side effects and quicker onset of action.
However, poor asthma control is common, despite available effective treatment .This is partially related to low adherence and to difficulties in using inhaler devices. Among patients with chronic respiratory disorders, 18% discontinued the prescribed inhaler treatment because of troubles with the device (Santus 2012). Some devices are not easy to handle, or require breathing abilities, which reduce the effectiveness in real life, especially in elderly.Since mistakes in inhaler technique are very common affecting drug delivery and efficacy, a correct inhaler technique training is fundamental. A single site study in 2012 (Press 2012) found that patients given verbal and written instructions followed by demonstrations of inhaler use had better inhaler technique than patients given verbal and written instructions only. The authors concluded that larger multi-centred studies were needed to evaluate hospital-based-education.
Proposals to improve inhalers use are based on three key points:
- the choice of the best device paying attention to patient needs and abilities (personalized therapy)
- a complete explanation of the correct use (patient training)
- a regular re-check to evaluate the maintenance of a correct technique (monitoring)
The study consists of two phases:
- A cross over phase: 3 periods of 1 week each. During the training visit at the beginning of each week period, patients will be instructed on the correct use of one of the 3 devices. Correct use and maintenance of correct use after 1 week will be assessed.
- A longitudinal phase: patient will be treated with the last inhaler device used during the cross over phase for 8 additional weeks.
The maximum time from screening to end of study visit is12 weeks, with a follow up taking place 30 days after the final visit .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spiromax Inhaler | Active comparator | Device: Spiromax (budesonide/formoterol), Device: Turbohaler (budesonide/formoterol), Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)Evaluation of correct use of Spiromax inhaler - DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup |
| Turbohaler inhaler | Active comparator | Device: Spiromax (budesonide/formoterol), Device: Turbohaler (budesonide/formoterol), Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)Turbohaler® - Symbicort® 160/4.5 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate). Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup |
| Diskus Inhaler | Active comparator | Device: Spiromax (budesonide/formoterol), Device: Turbohaler (budesonide/formoterol), Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)Diskus® inhaler - Seretide Diskus 50/250 mcg ® or 50/500 mcg (50 mcg salmeterol \& 250/500 mcg fluticasone propionate). Dose of one inhalation twice a day for 1 week. Additional 8 weeks in one subgroup |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed consent. Written informed consent/assent signed and dated by the patient before conducting any study related procedure.
- Age. Male or female patients 60 years and older as of the Screening Visit (SV)
- Asthma or COPD diagnosis. Previous or new Asthma/COPD diagnosis in accordance with the Global Initiative for Asthma (GINA) or Global initiative for chronic Obstructive Lung Disease (GOLD).
- Severity of respiratory disease: Persistent asthma, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months duration. COPD, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months.
- Stable state. Patients without exacerbations and without change in the previous treatment for at least 4 weeks prior to the visit 1 as defined by clinical history.
Key exclusion criteria (9 listed)
- Asthma severity. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- COPD severity. COPD with a pre-bronchodilator FEV1 < 30% and/or FEV1 30-50% but requiring long term oxygen therapy.
- Exacerbations. Any asthma/COPD exacerbation within one month of the visit 1. A patient must not have had any hospitalisation for asthma/COPD within 6 months prior to the visit 1.
- Respiratory infections. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the visit 1.
- Comorbidities. Historical or current evidence of a clinically significant comorbidity including, but not limited to: cardiovascular (e.g. congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological (e.g. immunologic compromise), neuropsychological, endocrine (e.g. uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g. poorly-controlled peptic ulcer, gastroesophageal reflux disease), pulmonary (e.g. bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, lung cancer) or history of a positive test for HIV, hepatitis B or hepatitis C infection. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated 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 |
|---|---|---|
| Spiromax (budesonide/formoterol)DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup | Device | Diskus Inhaler, Spiromax Inhaler, Turbohaler inhaler |
| Turbohaler (budesonide/formoterol)Turbohaler® (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate)- Symbicort® 160/4.5. Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup | Device | Diskus Inhaler, Spiromax Inhaler, Turbohaler inhaler |
| Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)Diskus® inhaler(50mcg salmeterol\&250/500mcg fluticasone propionate)-Seretide Diskus 50/250mcg® or 50/500mcg.Dose of 1inhalation twice a day for1 week.Additional 8 weeks in1subgroup | Device | Diskus Inhaler, Spiromax Inhaler, Turbohaler inhaler |
Primary outcome
Usability of Spiromax , Turbuhaler and Diskus devices
Time frame: day 1
number of attemps required to acheive optimal use
3 secondary outcomes
Short term maintenance of correct use
Time frame: 1 weeks of treatment (cross sectional phase)
Long term maintenance of correct use
Time frame: 8 weeks of treatment at the end of the longitudinal phase
Patient's preference for different devices
Time frame: 8 weeks of treatment at the end of the longitudinal phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Alberto Papi, MD study chair
Università degli Studi di Ferrara
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiromax (budesonide/formoterol), Turbohaler (budesonide/formoterol) and Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) in people with Asthma and COPD, run by Consorzio Futuro in Ricerca at 3 sites in Italy.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability of Spiromax , Turbuhaler and Diskus devices (time frame: day 1). 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 29 Jan 2018.