None listed
Conditions
Brief summary
Breathlessness is one of the most common and troubling symptoms that people with asthma report. Breathlessness may have many causes, such as reduced lung function, an abnormal breathing pattern, vocal cord dysfunction, obesity, or anxiety. Little research has been done to understand the different causes of breathlessness in asthma or people’s experiences of breathlessness. This study will use different methods to characterise breathlessness. By doing these assessments we will better understand how breathlessness impacts people with asthma, how breathlessness differs according to how severe your asthma is, and what the multiple causes of breathlessness are. We will also gain a better understanding of the experience of people living with breathlessness that is caused by a condition known as vocal cord dysfunction. This condition is known to cause breathlessness and frequently overlaps with asthma.
Interventions
A cross-sectional observational study will be conducted in stable severe and non-severe asthma participants.
Participants will consent to-
1) Completing the tests involved in the study
2) Completing questionnaires to obtain research data
3) A copy of their results being sent to their General Practitioner
4) Allowing research personnel access to their medical record and to record attendance and lung function results in their file.
All participants will undergo a multidimensional assessment of
A cross-sectional observational study will be conducted in stable severe and non-severe asthma participants. Participants will consent to- 1) Completing the tests involved in the study 2) Completing questionnaires to obtain research data 3) A copy of their results being sent to their General Practitioner 4) Allowing research personnel access to their medical record and to record attendance and lung function results in their file. All participants will undergo a multidimensional assessment of breathlessness over 2 visits 2-4 weeks apart that will take no longer than 2.5 hours per visit. The multidimensional assessment involves the participant undergoing measures of blood pressure, height and weight, pulmonary function testing, saline challenge, six minute walk test, blood collection, physical activity monitoring, respiratory inductive plethysmography (RIP), fractional exhaled nitric oxide (FeNO), capnography, breath hold time, bioimpedence analysis and a laryngoscopy. The participant will also complete some questionnaires to gain information about general health or quality of life, medical history and medications, asthma symptoms, overall well-being and mental health, activity levels and problems related to breathlessness. A subset of participants who complete the multidimensional assessment and are identified as having vocal cord dysfunction (VCD) will be invited to participate in a 2-hour qualitative interview on a later day. Participants with VCD or breathlessness from other causes will also be invited to participate in a 3-hour qualitative art activity on later day.
Sponsors
University of Newcastle
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All Participants -18 years of age or older. -Confirmed diagnosis of asthma -Evidence of variable airflow limitation within the last 10 years: *Bronchodilator response (BDR) greater than or equal to 200ml OR greater than or equal to 12% (post-bronchodilator FEV1 following administration of 400µg salbutamol). *Airway hyper-responsiveness (AHR) in response to any standard challenge agent. or *Peak flow variability (diurnal; variation greater than or equal to 15% or greater than or equal to 50ml). Severe Asthma Participants Severe asthma is defined as asthma requiring high-dose inhaled corticosteroids with a second controller to prevent “uncontrolled” disease or disease that remains “uncontrolled” despite therapy. To meet the criteria for severe asthma, participants will additionally require the following to be met: 1. Prescribed high-dose inhaled corticosteroids (>1000µg beclomethasone equivalent) PLUS a second controller (may include long-acting beta agonists; and/or long-acting muscarinic antagonists, and/or maintenance oral corticosteroids greater than or equal to 50% of the past year; and/or montelukast; and/or theophylline). or Requires a monoclonal antibody (mAb) therapy to control asthma or remains uncontrolled despite a mAb. 2. Have uncontrolled asthma determined by: a. scores on the Asthma Control Questionnaire greater than or equal to 1.5; b. and/or frequent severe exacerbations (greater than or equal to 2 systemic corticosteroids of 3 or more days each in the previous year); c. and/or a serious exacerbation in the previous year (hospitalisation, intensive care unit stay, mechanical ventilation); d. and/or persistent airflow limitation (pre-bronchodilator FEV1 <80% predicted in the face of a reduced FEV1/FVC <0.7). Inclusion for qualitative studies Qualitative Interview: Participants with asthma who have co-existing VCD defined either a fall in FIF of greater than or equal to 25% or demonstrated paradoxical vocal fold movement on laryngoscopy. Art Based Study: Two groups will be recruited. 1) Those with severe asthma and breathlessness but not VCD. That is a score of greater than or equal to 2 on the Modified Medical Research Council Dyspnea Scale [31] and either a fall in FIF of <25% or no demonstrated paradoxical vocal fold movement during laryngoscopy. 2) Those with severe asthma, breathlessness and VCD. That is a score of greater than or equal to 2 on the Modified Medical Research Council Dyspnea Scale and either a fall in FIF of greater than or equal to 25% or demonstrated paradoxical vocal fold movement on laryngoscopy.
Exclusion criteria
1. Pregnant. 2. High dependence on medical care, including recent intensive care unit admission. 3. Significant life-limiting comorbidity. 4. Current lung cancer or other blood, lymphatic or solid organ malignancy. 5. Primary diagnosis of a lung disease other than asthma. 6. Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding verbal instructions. 7. Inability to attend study visits. 8. Exacerbation (use of oral corticosteroids or an increase from maintenance dose of oral corticosteroids for greater than or equal to 3 days) in the previous four weeks. These participants will have their visit postponed.
Outcome results
None listed