AsthmaNCT01455545
Impact of Adherence to Treatment in Asthma Control
An observational study of Asthma, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Aug 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with good asthma control according to the Asthma Control Test (ACT) score; b) 50 patients with bad control asthma according to the ACT score.
Who may be able to join
- Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Guadalajara
Guadalajara, Castille-La Mancha, 19002
About this study
Official title: Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire and Prescription Account.
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.
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma, Degree of Control, Exhaled Nitric Oxide, Asthma Control Test
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (10)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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 .
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Carlos Almonacid Sanchez, Phd, MD, Principal investigator, Sociedad Española de Neumología y Cirugía Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455545
- Sponsor's protocol ID
- HUGU ASMA 001
- Status last verified
- Jun 2013
- First submitted
- 10 Oct 2011
- Last updated
- 28 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire and Prescription Account.
- ClinicalTrials.gov ID
- NCT01455545
- Acronym / sponsor ID
- HUGU ASMA 001
- Conditions
- Asthma
- Keywords
- Asthma, Degree of Control, Exhaled Nitric Oxide, Asthma Control Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Posted 28 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with good asthma control according to the Asthma Control Test (ACT) score; b) 50 patients with bad control asthma according to the ACT score.
Key inclusion criteria (1 listed)
- Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.
Time frame: 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.
Time frame: 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.
10 secondary outcomes
Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.
Time frame: 4 weeks
Gender According to Level of Asthma Control.
Time frame: 4 weeks
Smoking Habit According to Level of Asthma Control.
Time frame: 4 weeks
Obesity According to Level of Asthma Control.
Time frame: 4 weeks
Rhinitis According to Level of Asthma Control.
Time frame: 4 weeks
Sinusitis According to Level of Asthma Control.
Time frame: 4 weeks
Gastroesophageal Reflux According to Level of Asthma Control.
Time frame: 4 weeks
Concomitant Psychiatric Disorders According to Level of Asthma Control.
Time frame: 4 weeks
Pulmonary Function Test (Spirometry) According to Level of Asthma Control.
Time frame: 4 months
Asthma Severity According to Level of Asthma Control.
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Carlos Almonacid Sanchez, Phd, MD principal investigator
Sociedad Española de Neumología y Cirugía Torácica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 1 inclusion and 2 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 28 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.