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Impact of Adherence to Treatment in Asthma Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01455545
Recruitment Status : Completed
First Posted : October 20, 2011
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Asthma
Enrollment 100
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.
Pre-assignment Details  
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points. Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
Period Title: Overall Study
Started 55 45
Completed 55 45
Not Completed 0 0
Arm/Group Title Asthmatic Patients
Hide Arm/Group Description

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).

Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
3
   3.0%
Between 18 and 65 years
87
  87.0%
>=65 years
10
  10.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
45.25  (15.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
66
  66.0%
Male
34
  34.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 100 participants
100
1.Primary Outcome
Title Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
34
(22 to 41)
32
(22.5 to 43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.967
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.999
Confidence Interval (2-Sided) 95%
0.962 to 1.037
Estimation Comments [Not Specified]
2.Primary Outcome
Title Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
adherence to inhalers >= 80% 33 26
adherence to inhalers < 80% 22 19
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.822
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.096
Confidence Interval (2-Sided) 95%
0.492 to 2.441
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The same as primary outcome.
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Median (Inter-Quartile Range)
Unit of Measure: units on a scale (parts per billion)
27
(17 to 45)
28
(18.5 to 40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.001
Confidence Interval (2-Sided) 95%
0.985 to 1.018
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Gender According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
male 16 18
female 39 27
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.625
Confidence Interval (2-Sided) 95%
0.706 to 3.739
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Smoking Habit According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
current smoker 7 5
non smoker 25 28
former smoker 23 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Chi - square
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.217
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Obesity According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
Normal 28 25
overweight - obesity 27 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.643
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.830
Confidence Interval (2-Sided) 95%
0.376 to 1.829
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Rhinitis According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Asthmatic Patients Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
yes 18 21
no 37 24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control Asthmatic Patients, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.556
Confidence Interval (2-Sided) 95%
0.247 to 1.253
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Sinusitis According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Asthmatic Patients Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
yes 1 4
no 54 41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control Asthmatic Patients, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.190
Confidence Interval (2-Sided) 95%
0.020 to 1.763
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Gastroesophageal Reflux According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control. Bad control if ACT score < or = 19.
Patients with asthma and goog control. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 44
Measure Type: Number
Unit of Measure: participants
yes 2 0
no 53 45
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.196
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.849
Confidence Interval (2-Sided) 95%
1.541 to 2.219
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Concomitant Psychiatric Disorders According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
yes 7 2
no 48 43
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.135
Confidence Interval (2-Sided) 95%
0.618 to 15.91
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Pulmonary Function Test (Spirometry) According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Mean (Standard Deviation)
Unit of Measure: percentage of the theoretical
84.23  (16.49) 94.93  (18.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.038
Confidence Interval (2-Sided) 95%
1.012 to 1.065
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Asthma Severity According to Level of Asthma Control.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bad Control Good Control
Hide Arm/Group Description:
Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
Overall Number of Participants Analyzed 55 45
Measure Type: Number
Unit of Measure: participants
mild-moderate asthma 24 31
severe asthma 31 14
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bad Control, Good Control
Comments Ho = no differences between both groups H1= there are differences between both groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.350
Confidence Interval (2-Sided) 95%
0.153 to 0.799
Estimation Comments [Not Specified]
Time Frame This is a cross-sectional study in which all data are collected in a single visit. There is no treatment previously modified or new drugs were tested. No intervention was performed so it can not be collected any adverse effects.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bad Control Asthmatic Patients Good Control
Hide Arm/Group Description Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score. Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
All-Cause Mortality
Bad Control Asthmatic Patients Good Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bad Control Asthmatic Patients Good Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bad Control Asthmatic Patients Good Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
This is an observational (cross-sectional )study, with the limitations and biases associated. Patients have not been randomized.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carlos Almonacid
Organization: SESCAM - HOSPITAL UNIVERSITARIO DE GUADALAJARA
Phone: +34 655 53 44 75
EMail: caralmsan@gmail.com
Layout table for additonal information
Responsible Party: CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01455545    
Other Study ID Numbers: HUGU ASMA 001
First Submitted: October 10, 2011
First Posted: October 20, 2011
Results First Submitted: August 17, 2012
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013