- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757209
Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD (PMC-101-APT)
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).
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bari
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Cassano delle Murge, Bari, Italy, 70020
- 3) Fondazione S. Maugeri - IRCCS - Dipartimento di Pneumologia Riabilitativa
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Fe
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Ferrara, Fe, Italy, 44124
- University Hospital S Anna
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Varese
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Tradate, Varese, Italy, 21049
- 4) Clinica di Malattie dall'Apparato Respiratorio Fondazione Salvatore Maugeri
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.).
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Spiromax Inhaler
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 |
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® (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® 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
|
Active Comparator: Turbohaler inhaler
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 |
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® (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® 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
|
Active Comparator: Diskus Inhaler
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 |
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® (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® 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of Spiromax , Turbuhaler and Diskus devices
Time Frame: day 1
|
number of attemps required to acheive optimal use
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day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short term maintenance of correct use
Time Frame: 1 weeks of treatment (cross sectional phase)
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Ease of use: Number of errors after 1 week use
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1 weeks of treatment (cross sectional phase)
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Long term maintenance of correct use
Time Frame: 8 weeks of treatment at the end of the longitudinal phase
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number of errors after 8 additional weeks of use
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8 weeks of treatment at the end of the longitudinal phase
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Patient's preference for different devices
Time Frame: 8 weeks of treatment at the end of the longitudinal phase
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Patient's preference for different devices b using PAPSQ questionnaire and VAS scales
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8 weeks of treatment at the end of the longitudinal phase
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Alberto Papi, MD, Università degli Studi di Ferrara
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Fluticasone
- Xhance
- Salmeterol Xinafoate
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- PMC-101-APT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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