An observational study in COPD and Asthma, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational
Obstructive ventilatory disorders, including chronic obstructive pulmonary disease (COPD), asthma, and pulmonary emphysema, are chronic conditions characterized by progressive airflow limitation and worsening dyspnea, leading to increasing restrictions in daily activities and quality of life.
Although these diseases are not curable, early diagnosis and appropriate treatment can slow disease progression, reduce exacerbations, and preserve functional capacity and well-being. Adherence to prescribed inhaled therapies is therefore essential from the earliest stages of the disease. However, both clinical experience and published evidence suggest that many patients with COPD and asthma experience poor disease control, relapses, and exacerbations due to inadequate inhaler use and suboptimal treatment adherence.
Previous research has explored treatment satisfaction among patients with COPD and examined perceptions and beliefs regarding pharmacological therapies in other chronic conditions, such as diabetes, depression, and autoimmune diseases. Studies have also highlighted the importance of adopting a patient-centered approach when selecting inhaler devices based on individual patient characteristics. Nevertheless, little is known about how patients with obstructive ventilatory disorders perceive inhaled therapies and their role in disease management.
The aim of this study is to investigate patients' perceptions of inhalation therapy, focusing on factors that influence its use, the value attributed to inhaled medications, preferences regarding the route of administration, awareness of the underlying disease, perceived barriers to treatment, and beliefs about medications in general.
Understanding how patients perceive both the treatment and its route of administration is a key component of patient engagement, which emphasizes patients' active involvement in managing their health and healthcare pathway.
Currently, no validated tools, either internationally or in Italian, are specifically designed to assess perceptions of the usefulness and effectiveness of inhalation therapy in patients with obstructive ventilatory disorders. This study therefore aims to address an important gap in the literature and support the development of more patient-centered therapeutic strategies.
STUDY OBJECTIVE
This project aims to optimize the diagnostic and therapeutic pathway of patients with obstructive ventilatory disorders (COPD, asthma, and pulmonary emphysema), with the goal of improving disease awareness, treatment appropriateness, and adherence to prescribed therapies.
Primary Objective
The primary objective of the study is to investigate patients' perceptions of the usefulness and effectiveness of inhalation therapy, as well as any difficulties they may encounter in its use and management, through a specifically designed structured interview.
Secondary Objectives
To qualitatively evaluate and compare patients' perceptions of the usefulness and effectiveness of other treatment modalities, including oral therapies, intravenous/intramuscular treatments, oxygen therapy, and respiratory physiotherapy.
Materials and Methods Study Population
The study population will consist of patients with obstructive ventilatory disorders (COPD, asthma, or pulmonary emphysema) admitted to the Respiratory Rehabilitation Unit as inpatients, receiving short-term care (MAC), attending outpatient visits at the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia), or referred to the outpatient clinic of the Respiratory Medicine Unit at Spedali Civili of Brescia.
Inclusion Criteria Confirmed spirometric diagnosis of COPD and/or pulmonary emphysema, or functional/clinical diagnosis of asthma according to ATS/ERS criteria.
Diagnosis established at least 6 months before enrollment. Signed informed consent confirming the patient's voluntary participation in the study.
Exclusion Criteria Known cognitive impairment or Mini-Mental State Examination score \< 24. Refusal to participate.
The project will be conducted through five main phases: (1) preliminary audit and development of the structured interview, (2) protocol finalization, (3) interview administration and questionnaire completion, (4) data analysis, and (5) preparation of a scientific manuscript for publication.
Phase 1 - Audit
The first phase will involve the establishment of a multidisciplinary audit team composed of two psychologists, one psychology fellow, two pulmonologists, two nurses, two physiotherapists, and two expert patients. Drawing on the scientific literature, professional expertise, and personal experience, the team will develop a structured interview specifically designed to explore patients' perceptions of inhalation therapy.
The structured interview will include closed-ended questions, multiple-choice items, dichotomous yes/no questions, and 5-point Likert-scale ratings. The interview will address the following key domains:
Patients' perceptions and opinions regarding inhalation therapy (e.g., method of administration, frequency and ease of use, perceived effectiveness, reasons for prescription, and perceived disease severity associated with its use).
Disease awareness and knowledge.Perceptions of treatment in general and therapy preferences. Motivation and willingness to adhere to prescribed treatments.
A preliminary, non-exhaustive list of potential items includes:
Do you think your condition will significantly worsen over time? Have you ever received educational material about your respiratory disease? Do you consider your condition a serious chronic illness? Do you think your actions can help control your symptoms? Do you believe your actions can influence the course of your disease? What type of medication do you prefer to take? Have you ever considered changing your current treatment? Which type of treatment do you find easiest to take and maintain over time? Do you find inhalation therapy easy to use? Do you consider inhaled therapy somewhat unnecessary when symptoms are absent?
Phase 2 - Protocol Finalization
In addition to the structured interview, the protocol will include assessment tools investigating patients' perceptions of the usefulness and effectiveness of inhalation therapy.
Once approved by the expert panel, the draft version of the structured interview will be administered to five patients to assess its clarity, comprehensibility, and feasibility. Feedback obtained from this pilot testing phase will be used to refine and finalize the interview.
Based on available evidence from the scientific literature, the protocol will also incorporate selected sections of validated questionnaires currently used in clinical practice:
A. Medication Use Assessment
Section 3 of the InQoL questionnaire will be considered.
B. Assessment of Medication Beliefs
The Beliefs about Medicines Questionnaire (BMQ) will be administered.
Phase 3 - Interview Administration and Assessment Scales
Following protocol finalization, the study will be conducted among patients admitted to the Respiratory Rehabilitation Unit, those receiving care in the Medical-Surgical Ward, and outpatients attending either the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia) or the Respiratory Medicine outpatient clinic at Spedali Civili of Brescia.
Patients who agree to participate will complete both the structured interview developed during Phase 1 and the assessment questionnaires identified in Phase 2. Administration will be performed by trained personnel, including a clinical psychologist or psychology fellow.
Both the interview and questionnaires will be provided in paper format. The estimated completion time will not exceed 60 minutes.
Sample Size Calculation
Assuming that 50% of patients perceive inhalation therapy as not useful, only slightly useful, or not particularly effective, a sample of 43 patients will be required to estimate this prevalence with a precision of ±15% (95% confidence interval: 35%-65%) and a confidence level of 95%.
Considering a potential dropout rate of approximately 15% due to refusal, clinical exacerbation, or transfer to another healthcare facility, a total of 50 patients will be recruited.
Sample size calculations for proportions were performed using the OpenEpi software (https://www.openepi.com/SampleSize/SSPropor.htm).
The final version of the structured interview will then be administered to 50 consecutive patients attending the Respiratory Rehabilitation Unit as inpatients, MAC patients, or outpatients at either the Istituti Clinici Scientifici Maugeri in Lumezzane (Brescia) or the Respiratory Medicine outpatient clinic at Spedali Civili of Brescia over an anticipated recruitment period of approximately 10 months.
All participating adults, regardless of sex, must meet the predefined inclusion and exclusion criteria and provide written informed consent together with authorization for personal data processing.
Measurements
For each enrolled participant, the following data will be collected:
Baseline Data Collection
Anthropometric and demographic data
Age Sex Body Mass Index
Clinical data
Disease duration Use of oxygen therapy Current medications Presence of comorbidities Presence of a caregiver
Functional data
Forced Expiratory Volume in 1 second (FEV1) (% predicted) Forced Vital Capacity (FVC) (% predicted) FEV1/FVC ratio
A structured interview investigating perceptions of inhalation therapy will be administered and will include:
Assessment scales exploring beliefs about respiratory medications, medications in general, and the perceived benefits and adverse effects associated with alternative therapeutic modalities (oral treatments, intravenous/intramuscular therapies, oxygen therapy, and respiratory physiotherapy), as described in Phase 2.
Patient-rated disease severity using a 10-point Likert scale (0 = worst; 10 = best).
Clinician-rated disease severity using the same 10-point Likert scale (0 = worst; 10 = best).
Phase 4 - Data Analysis
Descriptive analyses will be performed for each item included in the structured interview.
Interview items will also be grouped into domains reflecting:
Perceived usefulness of medical therapy in general. Perceived usefulness of inhalation therapy. Perceived effectiveness of inhalation therapy.
For exploratory purposes, a composite score will be calculated for each domain and correlated with scores obtained from a different questionnaire (i.e.Beliefs about Medicines Questionnaire).
Associations between interview scores and questionnaire scores will be evaluated using Spearman's rank correlation coefficient.
Differences in perceptions of benefits and side effects across treatment modalities will be assessed using one-way Analysis of Variance or, when appropriate, the non-parametric Kruskal-Wallis test.
Statistical analyses will be performed using R (Vienna, Austria). Statistical significance will be defined as a two-sided p-value \< 0.05.
Phase 5 - Scientific Manuscript Preparation
The findings generated by the study will be used to prepare at least one scientific manuscript for publication in a peer-reviewed journal.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 101 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients with a diagnosis of chronic obstructive pulmonary disease (COPD) or Asthma were screened at the Respiratory Rehabilitation Unit of the Istituti Clinici Scientifici Maugeri IRCCS, while patients diagnosed with asthma were screened at the Specialized Severe Asthma Unit of the ASST Spedali Civili.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutive adult patients with a diagnosis of chronic obstructive pulmonary disease (COPD) were screened at the Respiratory Rehabilitation Unit of the Istituti Clinici Scientifici Maugeri IRCCS. The subjects enrolled in the study had to fulfil the following clinical criteria: 1) confirmed clinical and spirometric diagnosis of COPD; 2) having received a diagnosis for at least six months; 3) use of inhalation therapy for at least three months; 4) absence of cognitive decline in the anamnesis.
Other: Survey
Patients diagnosed with asthma were screened at the Specialized Severe Asthma Unit of the ASST Spedali Civili. The subjects enrolled in the study had to fulfil the following clinical criteria: 1) confirmed asthma based on lung function assessment according to ATS/ERS criteria; 2) having received a diagnosis for at least six months; 3) use of inhalation therapy for at least three months; 4) absence of cognitive decline in the anamnesis.
Other: Survey
The present study was designed to investigate the perceived usefulness and effectiveness of inhaled therapy among patients with asthma and COPD. Specifically, it sought to identify factors influencing treatment use, the value attributed to inhaled therapy throughout the disease course, and potential barriers to its administration and management. A structured interview was developed through a multidisciplinary audit and subsequently finalized within the study protocol. In addition, participants completed validated assessment tools evaluating perceptions of treatment usefulness and effectiveness, together with beliefs about medications.
AUDIT
The structured interview must cover several areas of investigation, namely: 1. specifically, patients' perceptions and opinions regarding inhalation therapy (e.g., administration methods, frequency, and ease of use; perceived effectiveness; reasons for prescription; and perceived severity of the disease associated with this therapy); 2. the patient's awareness of and knowledge about the disease, 3. perceptions of therapy in general and patient preferences; and 4. motivation to adhere to prescriptions.
Time frame: Baseline
QUESTIONNAIRE
The final version of the questionnaire is organized into four sections. The first part of the questionnaire is designed to collect the patient's medical history: it includes questions about education level, employment, presence of a caregiver, type of diagnosis and its duration, the type of inhalation therapy used, number of administrations, presence of comorbidities, other medications taken, and whether the patient is autonomous in managing his/her pharmacological therapy. The second part of the questionnaire explores the patients' perception of their condition. The third part focuses on therapies in general, while the fourth and final section concentrates exclusively on inhalation therapy. The questionnaire does not yield an overall score, and therefore no minimum or maximum total score can be determined. Accordingly, each item will be considered and analyzed individually.
Time frame: Starting from month 1
BELIEFS
In addition to the structured interview, participants completed questionnaires evaluating treatment perceptions and beliefs about medication. The Beliefs about Medicines Questionnaire (BMQ), a validated instrument designed to assess cognitive representations of medication, was included in the study protocol. Patients rated their agreement with each statement on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The BMQ comprises a Specific section, assessing beliefs about the necessity of prescribed medications and concerns related to their use, and a General section, evaluating beliefs about medicines as a class of treatment.
Time frame: Starting from month 1
Plan to share: No
Ran from Apr 2024 to primary completion in Jul 2025, 15 months.
Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's 15 months is below that.
Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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