AsthmaNCT01221350
Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients
A study testing Lipoic acid in people with Asthma and Allergic Rhinitis, run by Centro Universitario de Ciencias de la Salud, Mexico at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- Lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesMexico
- Study dates
- Nov 2010to Aug 2012
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients (≥18 and ≤ 75 years of age) female or male
- Willingness to participate and comply with procedures by signing a written informed consent
- Moderate/severe persistent allergic rhinitis according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines with a history of intermittent, mild persistent or moderate persistent asthma according to GINA guidelines
- Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; bush mix; tree mix; grass mix; weed mix, cat; or dog.
- All prior medication washout times had been observed
- Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception
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- Negative urine pregnancy test
- Without a concomitant chronic medical condition (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- Willingness to adhere to the dosing and visit schedules
Who cannot join
- Pregnant or breastfeeding
- Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
- Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period
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- Patients undergoing a progressive course of immunotherapy. Subjects on a regular maintenance schedule prior to the screening visit are eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
- Concomitant medical problem
- In a situation or condition that could interfere with participation in the study
- Allergic or sensitivity to the study drug or its excipients
- History of inadequate adherence to treatment
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 44340
Departamento de Fisiología, CUCS, UdeG
Guadalajara, Jalisco, 44348
About this study
Official title: Exploratory Study of Lipoic Acid Supplementation on Oxidative Stress, Inflammatory and Functional Markers in Asthmatic Patients: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial.
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.
Read the 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.
- 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.
- Study design. A randomized, double blind, placebo controlled parallel study
- 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.
- 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.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- Lipoic acid, Placebo
- Keywords
- Asthma, Allergic rhinitis, Respiratory disease, Allergy, Lipoic acid, Thioctic acid, Antioxidant, Oxidative stress
- Medical subject headings
- Asthma, Rhinitis, Allergic, Respiration Disorders, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic acidDietary supplement
Also called Thioctic Acid, Alpha-Lipoic Acid
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.
PlaceboDietary supplement
Also called Placebos, Placebo effect
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
| Study group | Role | What they receive |
|---|---|---|
| Lipoic acid | Experimental | Lipoic acid 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days Receives: Dietary Supplement: Lipoic acid |
| Placebo | Placebo comparator | Placebo (two placebo capsules) orally once daily in the morning during 60 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometric FVC Values at Baseline
Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Measured: Baseline
Spirometric FVC Values at Endpoint
Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Measured: 60 days
Spirometric FEV1 Values at Baseline
Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Measured: Baseline
Spirometric FEV1 Values at Endpoint
Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Measured: 60 days
Spirometric FEF Values at Baseline
Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
Measured: Baseline
Spirometric FEF Values at Endpoint
Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
Measured: 60 days
Secondary outcomes (12)
Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline
Induced sputum of GSH and GSSG levels at baseline. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.
Measured: Baseline
Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint
Change in the induced sputum of antioxidant parameters GSH and GSSG levels after 60 days of treatment. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.
Measured: 60 days
Induced Sputum Carbonylated Proteins at Baseline
Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products
Measured: Baseline
Induced Sputum Carbonylated Proteins at Endpoint
Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products.
Measured: 60 days
Induced Sputum Eosinophils at Baseline
Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.
Measured: Baseline
Induced Sputum Eosinophils at Endpoint
Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.
Measured: 60 days
Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline
Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of immunoglobulin E (IgE) in B cells. IL-4 was measured by ELISA.
Measured: Baseline
Inflammatory IL-4 Sputum Levels at Endpoint
Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of IgE in B cells. IL-4 was measured by ELISA.
Measured: 60 days
Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline
Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).
Measured: Baseline
Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint
Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).
Measured: 60 days
Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline
The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.
There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html).
Measured: Baseline
Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint
The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.
There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html).
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionAug 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.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, University of Guadalajara, Hospital Civil Juan I. Menchaca
- Responsible party
- Principal investigator, Fernando Siller-Lopez, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Fernando R. Siller Lopez, PhD, Principal investigator, Centro Universitario de Ciencias de la Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221350
- Sponsor's protocol ID
- UdeG-FSL-2010
- Other IDs
- Salud-2010-C01-140590
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2010
- Last updated
- 8 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kroegel C. [Global Initiative for Asthma Management and Prevention--GINA 2006]. Pneumologie. 2007 May;61(5):295-304. doi: 10.1055/s-2007-959180. German.
PubMed 17523070Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
PubMed 20816182Cho YS, Lee J, Lee TH, Lee EY, Lee KU, Park JY, Moon HB. alpha-Lipoic acid inhibits airway inflammation and hyperresponsiveness in a mouse model of asthma. J Allergy Clin Immunol. 2004 Aug;114(2):429-35. doi: 10.1016/j.jaci.2004.04.004.
PubMed 15316528Lee KS, Kim SR, Park SJ, Min KH, Lee KY, Jin SM, Yoo WH, Lee YC. Antioxidant down-regulates interleukin-18 expression in asthma. Mol Pharmacol. 2006 Oct;70(4):1184-93. doi: 10.1124/mol.106.024737. Epub 2006 Jul 5.
PubMed 16822930Patel BD, Welch AA, Bingham SA, Luben RN, Day NE, Khaw KT, Lomas DA, Wareham NJ. Dietary antioxidants and asthma in adults. Thorax. 2006 May;61(5):388-93. doi: 10.1136/thx.2004.024935. Epub 2006 Feb 7.
PubMed 16467075Miller AL. The etiologies, pathophysiology, and alternative/complementary treatment of asthma. Altern Med Rev. 2001 Feb;6(1):20-47.
PubMed 11207455Rahman I. Oxidative stress, chromatin remodeling and gene transcription in inflammation and chronic lung diseases. J Biochem Mol Biol. 2003 Jan 31;36(1):95-109. doi: 10.5483/bmbrep.2003.36.1.095.
PubMed 12542980Biewenga GP, Haenen GR, Bast A. The pharmacology of the antioxidant lipoic acid. Gen Pharmacol. 1997 Sep;29(3):315-31. doi: 10.1016/s0306-3623(96)00474-0.
PubMed 9378235Singh U, Jialal I. Alpha-lipoic acid supplementation and diabetes. Nutr Rev. 2008 Nov;66(11):646-57. doi: 10.1111/j.1753-4887.2008.00118.x.
PubMed 19019027Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.
PubMed 1549827Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.
PubMed 16522452Riedl MA, Saxon A, Diaz-Sanchez D. Oral sulforaphane increases Phase II antioxidant enzymes in the human upper airway. Clin Immunol. 2009 Mar;130(3):244-51. doi: 10.1016/j.clim.2008.10.007. Epub 2008 Nov 22.
PubMed 19028145Comhair SA, Erzurum SC. Redox control of asthma: molecular mechanisms and therapeutic opportunities. Antioxid Redox Signal. 2010 Jan;12(1):93-124. doi: 10.1089/ars.2008.2425.
PubMed 19634987Shay KP, Moreau RF, Smith EJ, Smith AR, Hagen TM. Alpha-lipoic acid as a dietary supplement: molecular mechanisms and therapeutic potential. Biochim Biophys Acta. 2009 Oct;1790(10):1149-60. doi: 10.1016/j.bbagen.2009.07.026. Epub 2009 Aug 4.
PubMed 19664690
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Lipoic Acid Supplementation on Oxidative Stress, Inflammatory and Functional Markers in Asthmatic Patients: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial.
- ClinicalTrials.gov ID
- NCT01221350
- Acronym / sponsor ID
- UdeG-FSL-2010
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- Asthma, Allergic rhinitis, Respiratory disease, Allergy, Lipoic acid, Thioctic acid, Antioxidant, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico, University of Guadalajara, Hospital Civil Juan I. Menchaca
- Study start
- Nov 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Posted 30 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Study design. A randomized, double blind, placebo controlled parallel study
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoic acid | Experimental | Dietary Supplement: Lipoic acidLipoic acid 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (two placebo capsules) orally once daily in the morning during 60 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outpatients (≥18 and ≤ 75 years of age) female or male
- Willingness to participate and comply with procedures by signing a written informed consent
- Moderate/severe persistent allergic rhinitis according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines with a history of intermittent, mild persistent or moderate persistent asthma according to GINA guidelines
- Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; bush mix; tree mix; grass mix; weed mix, cat; or dog.
- All prior medication washout times had been observed
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipoic acidAlso: Thioctic Acid, Alpha-Lipoic AcidLipoic 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. | Dietary supplement | Lipoic acid |
| PlaceboAlso: Placebos, Placebo effectPlacebo (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 | Dietary supplement | Placebo |
Primary outcome
Spirometric FVC Values at Baseline
Time frame: Baseline
Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Spirometric FVC Values at Endpoint
Time frame: 60 days
Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Spirometric FEV1 Values at Baseline
Time frame: Baseline
Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Spirometric FEV1 Values at Endpoint
Time frame: 60 days
Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.
Spirometric FEF Values at Baseline
Time frame: Baseline
Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
Spirometric FEF Values at Endpoint
Time frame: 60 days
Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
12 secondary outcomes
Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline
Time frame: Baseline
Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint
Time frame: 60 days
Induced Sputum Carbonylated Proteins at Baseline
Time frame: Baseline
Induced Sputum Carbonylated Proteins at Endpoint
Time frame: 60 days
Induced Sputum Eosinophils at Baseline
Time frame: Baseline
Induced Sputum Eosinophils at Endpoint
Time frame: 60 days
Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline
Time frame: Baseline
Inflammatory IL-4 Sputum Levels at Endpoint
Time frame: 60 days
Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline
Time frame: Baseline
Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint
Time frame: 60 days
Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline
Time frame: Baseline
Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17523070Kroegel C. [Global Initiative for Asthma Management and Prevention--GINA 2006]. Pneumologie. 2007 May;61(5):295-304. doi: 10.1055/s-2007-959180. German.
- Background: PubMed 20816182Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
- Background: PubMed 15316528Cho YS, Lee J, Lee TH, Lee EY, Lee KU, Park JY, Moon HB. alpha-Lipoic acid inhibits airway inflammation and hyperresponsiveness in a mouse model of asthma. J Allergy Clin Immunol. 2004 Aug;114(2):429-35. doi: 10.1016/j.jaci.2004.04.004.
- Background: PubMed 16822930Lee KS, Kim SR, Park SJ, Min KH, Lee KY, Jin SM, Yoo WH, Lee YC. Antioxidant down-regulates interleukin-18 expression in asthma. Mol Pharmacol. 2006 Oct;70(4):1184-93. doi: 10.1124/mol.106.024737. Epub 2006 Jul 5.
- Background: PubMed 16467075Patel BD, Welch AA, Bingham SA, Luben RN, Day NE, Khaw KT, Lomas DA, Wareham NJ. Dietary antioxidants and asthma in adults. Thorax. 2006 May;61(5):388-93. doi: 10.1136/thx.2004.024935. Epub 2006 Feb 7.
- Background: PubMed 11207455Miller AL. The etiologies, pathophysiology, and alternative/complementary treatment of asthma. Altern Med Rev. 2001 Feb;6(1):20-47.
- Background: PubMed 12542980Rahman I. Oxidative stress, chromatin remodeling and gene transcription in inflammation and chronic lung diseases. J Biochem Mol Biol. 2003 Jan 31;36(1):95-109. doi: 10.5483/bmbrep.2003.36.1.095.
- Background: PubMed 9378235Biewenga GP, Haenen GR, Bast A. The pharmacology of the antioxidant lipoic acid. Gen Pharmacol. 1997 Sep;29(3):315-31. doi: 10.1016/s0306-3623(96)00474-0.
- Background: PubMed 19019027Singh U, Jialal I. Alpha-lipoic acid supplementation and diabetes. Nutr Rev. 2008 Nov;66(11):646-57. doi: 10.1111/j.1753-4887.2008.00118.x.
- Background: PubMed 1549827Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.
- Background: PubMed 16522452Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.
- Background: PubMed 19028145Riedl MA, Saxon A, Diaz-Sanchez D. Oral sulforaphane increases Phase II antioxidant enzymes in the human upper airway. Clin Immunol. 2009 Mar;130(3):244-51. doi: 10.1016/j.clim.2008.10.007. Epub 2008 Nov 22.
- Health Sciences Center, University of GuadalajaraLink provided by the sponsor.
- Hospital Civil de GuadalajaraLink provided by the sponsor.
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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.
Fernando R. Siller Lopez, PhD principal investigator
Centro Universitario de Ciencias de la Salud, Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipoic acid in people with Asthma and Allergic Rhinitis, run by Centro Universitario de Ciencias de la Salud, Mexico at 2 sites in Mexico.
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 9 inclusion and 11 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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. Some participants in this study may receive a placebo. 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 30 Jul 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?
Spirometric FVC Values at Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01221350, which also lists 14 linked publications.
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 8 Nov 2013.