Asthma
Conditions
Keywords
Asthma, Degree of Control, Exhaled Nitric Oxide, Asthma Control Test
Brief summary
This survey aims to analyze how adherence to treatment, using Ask-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma.
Detailed description
Duration of illness, poor adherence to treatment, gender, smoking habit, obesity, concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux) and concomitant psychiatric disorders may be responsible for an increase and perpetuation of the inflammatory response as well as a decreased response to treatment and may be easily identified clinically. PRIMARY OBJECTIVES: a) analyze how adherence to treatment, using ASK-20 questionnaire and prescription count, influences level of asthma control in a sample of patients with severe and moderate-mild asthma. SECONDARY OBJECTIVES: a) analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and the fraction exhaled of nitric oxide (FeNO); b) analyze the relation between the level of asthma control according to the ACT score and the gender. c) analyze the relation between the level of asthma control according to the ACT score and smoking habit. d) analyze the correlation between the level of asthma control according to the ACT score and obesity. e) analyze the relation between the level of asthma control according to the ACT score and concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux). f) analyze the relation between the level of asthma control according to the ACT score and concomitant psychiatric disorders. g) analyze the relation between the level of asthma control according to the ACT score and disease severity under the terms proposed by Global Initiative for Asthma (GINA). METHOD: This is a observational cross-sectional study that includes a sample made up of 50 patients with good asthma control and 50 patients with poor asthma control according to the Asthma Control Test(ACT). DEVELOPMENT OF THE STUDY After signing the informed consent, data will be collected including gender, smoking habit, alcohol consumption, environmental and employment factors, weight, height, body mass index (BMI), history of atopy, disease severity, rhinosinusitis, gastroesophageal reflux and concomitant psychiatric disorders and a standard physical examination. Measurement of asthma control with Asthma Control Test (ACT)will be performed. Then fraction exhaled of nitric oxide (FeNO)measurement and pulmonary function testing (forced spirometry and bronchodilator test) will be performed . DEVICES AND MEASUREMENTS: Clinical variables will be collected in a case report form (CRF) specially developed for the study. Functional study: The spirometry will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system. Bronchodilator test will be performed with albuterol and ipratropium bromide inhalation solution. FeNO levels will be measured of using the Filt's Vario analyzer which allows for bronchial or nasal tests, with a flow and volume meter Lilly-type pneumotachograph . Adherence to treatment will be assessed with the ASK-20 questionnaire and reviewing the number of prescriptions for asthma during the last 6 months.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Sociedad Española de Neumología y Cirugía Torácica
Study design
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .
Exclusion criteria
* Patients with a history of chronic obstructive pulmonary disease (COPD), residual pulmonary lesions or bronchiectasis seen on simple chest x-ray. * Presence of another associated acute or chronic inflammatory disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. | 4 weeks | The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence. Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma. To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers). |
| Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. | 4 weeks | Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Habit According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit. Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked. |
| Obesity According to Level of Asthma Control. | 4 weeks | Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI \> 30 obesity. Asthma control was measured by Asthma Control test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19 . |
| Rhinitis According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis. Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline. |
| Sinusitis According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group. |
| Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion). Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19. |
| Concomitant Psychiatric Disorders According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders. Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. |
| Pulmonary Function Test (Spirometry) According to Level of Asthma Control. | 4 months | Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry). Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. |
| Asthma Severity According to Level of Asthma Control. | 4 months | Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA). Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. |
| Gastroesophageal Reflux According to Level of Asthma Control. | 4 weeks | Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux. Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. |
| Gender According to Level of Asthma Control. | 4 weeks | Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender. Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19. |
Countries
Spain
Participant flow
Recruitment details
Dates of recruitment: Jan 2011 to Jan 2012. Location: medical clinic. Sampling method: Non-Probability Sample. Ages Eligible for Study: 16 yars to 80 years. Genders Eligible for Study: both.
Participants by arm
| Arm | Count |
|---|---|
| Asthmatic Patients Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or \< 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score \> 19.
In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA). | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Asthmatic Patients |
|---|---|
| Age, Categorical <=18 years | 3 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants |
| Age Continuous | 45.25 years STANDARD_DEVIATION 15.89 |
| Region of Enrollment Spain | 100 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.
The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence. Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma. To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers).
Time frame: 4 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Bad Control | Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. | 34 units on a scale | — |
| Good Control | Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. | 32 units on a scale | Inter-Quartile Range 15 |
Comparison: Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.p-value: 0.96795% CI: [0.962, 1.037]Regression, Logistic
Primary
Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.
Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. | adherence to inhalers >= 80% | 33 participants |
| Bad Control | Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. | adherence to inhalers < 80% | 22 participants |
| Good Control | Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. | adherence to inhalers >= 80% | 26 participants |
| Good Control | Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. | adherence to inhalers < 80% | 19 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.p-value: 0.82295% CI: [0.492, 2.441]Chi-squared
Secondary
Asthma Severity According to Level of Asthma Control.
Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA). Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.
Time frame: 4 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Asthma Severity According to Level of Asthma Control. | mild-moderate asthma | 24 participants |
| Bad Control | Asthma Severity According to Level of Asthma Control. | severe asthma | 31 participants |
| Good Control | Asthma Severity According to Level of Asthma Control. | mild-moderate asthma | 31 participants |
| Good Control | Asthma Severity According to Level of Asthma Control. | severe asthma | 14 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups.p-value: 0.01395% CI: [0.153, 0.799]Regression, Logistic
Secondary
Concomitant Psychiatric Disorders According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders. Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Concomitant Psychiatric Disorders According to Level of Asthma Control. | yes | 7 participants |
| Bad Control | Concomitant Psychiatric Disorders According to Level of Asthma Control. | no | 48 participants |
| Good Control | Concomitant Psychiatric Disorders According to Level of Asthma Control. | yes | 2 participants |
| Good Control | Concomitant Psychiatric Disorders According to Level of Asthma Control. | no | 43 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.p-value: 0.1595% CI: [0.618, 15.91]Chi-squared
Secondary
Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion). Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score \< or = 19 . Good control if ACT score \> 19.
Time frame: 4 weeks
Population: The same as primary outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bad Control | Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control. | 27 units on a scale (parts per billion) |
| Good Control | Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control. | 28 units on a scale (parts per billion) |
p-value: 0.86195% CI: [0.985, 1.018]Regression, Logistic
Secondary
Gastroesophageal Reflux According to Level of Asthma Control.
Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux. Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Gastroesophageal Reflux According to Level of Asthma Control. | no | 53 participants |
| Bad Control | Gastroesophageal Reflux According to Level of Asthma Control. | yes | 2 participants |
| Good Control | Gastroesophageal Reflux According to Level of Asthma Control. | no | 45 participants |
| Good Control | Gastroesophageal Reflux According to Level of Asthma Control. | yes | 0 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.p-value: 0.19695% CI: [1.541, 2.219]Chi-squared
Secondary
Gender According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender. Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Gender According to Level of Asthma Control. | male | 16 participants |
| Bad Control | Gender According to Level of Asthma Control. | female | 39 participants |
| Good Control | Gender According to Level of Asthma Control. | male | 18 participants |
| Good Control | Gender According to Level of Asthma Control. | female | 27 participants |
Comparison: Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi squarep-value: 0.25295% CI: [0.706, 3.739]Chi-squared
Secondary
Obesity According to Level of Asthma Control.
Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI \> 30 obesity. Asthma control was measured by Asthma Control test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19 .
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Obesity According to Level of Asthma Control. | Normal | 28 participants |
| Bad Control | Obesity According to Level of Asthma Control. | overweight - obesity | 27 participants |
| Good Control | Obesity According to Level of Asthma Control. | overweight - obesity | 20 participants |
| Good Control | Obesity According to Level of Asthma Control. | Normal | 25 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squarep-value: 0.64395% CI: [0.376, 1.829]Chi-squared
Secondary
Pulmonary Function Test (Spirometry) According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry). Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bad Control | Pulmonary Function Test (Spirometry) According to Level of Asthma Control. | 84.23 percentage of the theoretical | Standard Deviation 16.49 |
| Good Control | Pulmonary Function Test (Spirometry) According to Level of Asthma Control. | 94.93 percentage of the theoretical | Standard Deviation 18.04 |
p-value: 0.003t-test, 2 sided
p-value: 0.00595% CI: [1.012, 1.065]Regression, Logistic
Secondary
Rhinitis According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis. Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Rhinitis According to Level of Asthma Control. | yes | 18 participants |
| Bad Control | Rhinitis According to Level of Asthma Control. | no | 37 participants |
| Good Control | Rhinitis According to Level of Asthma Control. | yes | 21 participants |
| Good Control | Rhinitis According to Level of Asthma Control. | no | 24 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.p-value: 0.15595% CI: [0.247, 1.253]Chi-squared
Secondary
Sinusitis According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score \< or = 19. Good control if ACT score \> 19. Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Sinusitis According to Level of Asthma Control. | yes | 1 participants |
| Bad Control | Sinusitis According to Level of Asthma Control. | no | 54 participants |
| Good Control | Sinusitis According to Level of Asthma Control. | yes | 4 participants |
| Good Control | Sinusitis According to Level of Asthma Control. | no | 41 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.p-value: 0.10795% CI: [0.02, 1.763]Chi-squared
Secondary
Smoking Habit According to Level of Asthma Control.
Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit. Good control if ACT score \> 19. Bad control if ACT score \< or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked.
Time frame: 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bad Control | Smoking Habit According to Level of Asthma Control. | current smoker | 7 participants |
| Bad Control | Smoking Habit According to Level of Asthma Control. | non smoker | 25 participants |
| Bad Control | Smoking Habit According to Level of Asthma Control. | former smoker | 23 participants |
| Good Control | Smoking Habit According to Level of Asthma Control. | current smoker | 5 participants |
| Good Control | Smoking Habit According to Level of Asthma Control. | non smoker | 28 participants |
| Good Control | Smoking Habit According to Level of Asthma Control. | former smoker | 12 participants |
Comparison: Ho = no differences between both groups H1= there are differences between both groups. Chi - squarep-value: 0.217Chi-squared