Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to
      improve the quality of life of patients with asthma.

      The investigators will administrate 600 mg lipoic acid orally on a daily basis during two
      months concurrent with the patient anti-asthmatic therapy and evaluate the effects on
      resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related
      quality of life previous to the initial of the treatment and at 60 days of the supplementary
      therapy.
    

Detailed description: 
      Asthma is an inflammatory disease of high prevalence around the world. During development of
      asthma the presence of oxidative stress has been related to susceptibility and severity of
      the disease, thus making the use of antioxidant adjuvant therapy with lipoic acid (LA) an
      interesting treatment option. The objective of the study is to evaluate the efficacy of LA as
      an adjuvant treatment on functional, antioxidant, inflammatory, quality and control
      parameters of asthma in human subjects. The trial design is a randomized, double blind,
      placebo controlled parallel study.

      Adult patients (>18 years) with history of mild intermittent to moderate asthma according to
      the Global Initiative for Asthma (GINA) guidelines were enrolled. It was required a positive
      skin prick test (>3 mm) for at least two regional allergens. Patients were randomly assigned
      to receive lipoic acid or placebo for 60 days. Participants had an intermediate visit to the
      attending physician one month after initial of treatment to monitor adverse events and to
      undergo laboratory tests.

        1. Introduction. Asthma is an inflammatory disease of high prevalence around the world.
           During development of asthma the presence of oxidative stress has been related to
           susceptibility and severity of the disease, thus making the use of antioxidant adjuvant
           therapy with lipoic acid (LA) an interesting treatment option.

        2. Study design. A randomized, double blind, placebo controlled parallel study

        3. Methods. Participants and interventions: 55 patients with mild to moderate asthma from
           Hospital Civil "Juan I. Menchaca" in Guadalajara, Jalisco, México were included and
           randomized in block of 10 to receive; LA (600 mg/day) or placebo for eight weeks from
           January to October of 2011.

        4. Objective. To evaluate the efficacy of LA as an adjuvant treatment on functional,
           antioxidant, inflammatory, quality and control parameters of asthma in human subjects.
           Primary outcome: change on Forced expiratory volume in 1 second (FEV1), secondary
           outcomes were levels of Oxygen radical absorbance capacity (ORAC), glutathione (GSH),
           glutathione disulfide (GSSG), protein carbonyls, differential count of sputum cells,
           interleukin-4 (IL-4) and scores of quality of life and control of asthma questionnaires.
    

Intervention name(s): Lipoic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lipoic acid 600 mg dose (two 300 mg capsules) once daily in the morning. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed.; Placebo (two capsules filled with 300 mg vehicle) once daily in the morning during 60 days. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed
Other intervention name(s): Thioctic Acid; Alpha-Lipoic Acid; Placebos; Placebo effect
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Asthma; Allergic rhinitis; Respiratory disease; Allergy; Lipoic acid; Thioctic acid; Antioxidant; Oxidative stress