Quality of Life in People With Asthma

DEMONSTRATED ASTHMA MANAGEMENT AND QUALITY OF LIFE IMPROVEMENTS IN 28 DAYS.

An open-label test to evaluate the impact of Efficas Care on the quality of life in people with asthma was conducted nationwide during the summer allergy season. The participants added Efficas Care to their daily diet while continuing to use their asthma medications. Quality of Life assessments were made using the validated MiniAQLQ and ACQ questionnaires.

Overall, 71% of study participants reported an improvement in Quality of Life during the open label study. This change is of the same magnitude demonstrated in a placebo controlled study, where 72% of subjects with asthma taking Efficas Care versus 37.5% of subjects taking placebo reported improved quality of life after 4 weeks (Surette et al., manuscript in preparation).

Study participants reported a 44% mean improvement in Quality of Life from baseline after 4 weeks of taking Efficas Care (N = 65). The Quality of Life improvements attained were evident within 28 days, were statistically significant, and of meaningful magnitude.

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Asthma sufferers reported:

  • reduced wheezing and shortness of breath
  • improved sleep
  • significant reductions in rescue bronchodilator use
  • an increased ability to participate in physical activities

    * Mini AQLQ Asthma scale 1-7 with higher numbers indicating higher QOL
    *Juniper, E.F. et al., 1999a. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur. Respir. J. 14:32-38. Learn more >>

    *Asthma Control Questionnaire scale is 0-6 with lower numbers indicating greater asthma control. Subjects did not determine
    FEV1 in the Efficas Care open label test.
    *Juniper, E.F. et al., 1999b. Development and validation of a questionnaire to measure asthma control. Eur. Respir. J. 14:902-907. Learn more >>

Efficas care provides symptom relief, Improved quality of life and reduction in the use of bronchodilators for asthmatics.

Overall Improvement in Quality of Life Scores (p<0.001)

• 71% reported an improvement in quality of life
• Mean change from baseline in MiniAQLQ = 1.5 (1-7 scale)

Decreased Asthma Symptoms (p<0.001)

• 63% reported reduced asthma symptoms
• Mean change from baseline in MiniAQLQ symptom domain scores = 1.5 (1-7 scale)

Reduced Bronchodilator Use (p<0.001) 

•66% reported reduced limitations during moderate and strenuous physical activities 
• Mean change from baseline in MiniAQLQ physical activities questions scores = 1.4 (1-7 scale)

Reduced Sleep Disturbance (p<0.001) 

• 77% reported they were less bothered by sleep interference 
• Mean change from baseline in MiniAQLQ question 8 = 1.6 (1-7 scale) 
• Among those with severe sleep disturbance at baseline, 90% reported improvement

Improvements in Breathing (p<0.001) 

• 62% of asthma sufferers reported significant improvements in breathing (shortness of breath and wheezing) 
• Mean change from baseline in MiniAQLQ questions 1 & 10 = 1.5 (1-7 scale)

Improvements in Self-Reported Severity of Condition 

• Subjects’ assessments indicate improvements in the severity of their condition, even in those with moderately severe or severe symptoms at baseline

Study Design

A nation-wide open label test of the impact of medical food Efficas Care on Quality of Life in consumer populations with Asthma, Allergic Rhinitis and Eczema.
  • Population included 473 adults age 22 to 55 years, stratified by primary disease state; asthma (N=98), allergic rhinitis (N=146) and atopic dermatitis (N=229). The study was conducted during July/August 2006. The study objective was to evaluate the improvement in quality of life by using self-administered QOL instruments during 4 weeks of product use. Questions about allergy-related medical history, global symptoms severity, product performance and medication use were also administered. There were no dietary or medications restrictions during the test period.
  • 146 subjects with allergic rhinitis submitted enough data to allow post-use evaluation of the global questions. 109 subjects with allergic rhinitis completed QOL questionnaires both pre-and post-use, enabling statistical evaluation (Paired T-test). Responses to the global efficacy questions and to the detailed QOL questionnaires are comparable. 
  • 98 subjects with asthma submitted enough data to allow post-use evaluation of the global questions. 65 subjects with asthma completed QOL questionnaires both pre-and post-use, enabling statistical evaluation (Paired T-test). Responses to the global efficacy questions and to the detailed QOL questionnaires are comparable. 
  • The Mini Asthma Quality of Life Questionnaire (MiniAQLQ) was developed to measure the functional impairments that are most important for adults (17-70 years) with asthma. The MiniAQLQ instrument has 15 questions in exactly the same domains as the original AQLQ (symptoms, activities, emotions and environment). The MiniAQLQ has very good reliability, cross-sectional validity, responsiveness and longitudinal validity. A change in score of greater than 0.5 can be considered clinically important. Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J 1999; 14: 32-38.
  • The 7-item Asthma Control Questionnaire (ACQ) has been developed and validated to measure the adequacy of asthma control as defined by the international guidelines. Juniper, E.F. et al., 1999b. Development and validation of a questionnaire to measure asthma control. Eur. Respir. J. 14:902-907. In this study FEV1 measurements were not made. 
  • The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was developed to measure the problems that adults with rhinoconjunctivitis. In response to the need for a shorter version, the MiniRQLQ was developed which has 14 items in 5 domains (activity limitations, practical problems, nose symptoms, eye symptoms, non-nose/eye symptoms). The MiniRQLQ retains the 7-point response options and is self-administered. The MiniRQLQ has been fully validated. Juniper, E.F. et al., 2000. Development and validation of the Mini Rhinoconjunctivitis Quality of Life Questionnaire. Clin. Exp. Aller. 30: 132-140.