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1.
[Clinical effect of fluticasone propionate, montelukast sodium and ketotifen in treatment of cough variant asthma in children].
Zhu, XH, Tu, JW, Dai, JH
Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics. 2019;(4):393-398
Abstract
OBJECTIVE To study the clinical effect of different combinations of fluticasone propionate (Flu), montelukast sodium (Mon) and ketotifen (Ket) in the treatment of children with cough variant asthma (CVA). METHODS A total of 280 children with CVA who were admitted to the department of respiratory medicine from June 2015 to January 2018 were randomly divided into Flu+Mon+Ket, Flu+Mon, Flu+Ket, Mon+Ket, Flu, Mon and Ket groups, with 40 children in each group. The children in each group were given corresponding drug(s), and the course of treatment was 3 months for all groups. The condition of cough, cough symptom score, pulmonary function and adverse drug reactions were evaluated after 2 and 3 months of treatment. The children were followed up to observe recurrence. RESULTS After treatment, cough symptom score tended to decrease in all 7 groups, with increases in percentage of forced expiratory volume in 1 second (FEV1%) and percentage of predicted peak expiratory flow (PEF%). After 2 months of treatment, the Flu+Mon+Ket group had a significantly lower cough symptom score and significantly higher FEV1% and PEF% than the other groups (P<0.05). After 2 and 3 months of treatment, the Ket group had a significantly higher cough symptom score and significantly lower FEV1% and PEF% than the other groups (P<0.05). After 3 months of treatment, there were no significant differences in cough symptom score, FEV1% and PEF% among the other groups (P>0.05). There was a low incidence rate of adverse events in all 7 groups, and there was no significant difference among the 7 groups (P>0.05). The Ket group had a significantly higher recurrence rate of cough than the other groups (P<0.001), while there was no significant difference in this rate among the other groups (P>0.0024). CONCLUSIONS For children with CVA, a combination of Flu, Mon and Ket has a better clinical effect than a combination of two drugs and a single drug at 2 months of treatment and is safe. After 3 months of treatment, Flu or Mon alone has a similar effect to drug combination. Ket alone has a poor clinical effect and a high recurrence rate after drug withdrawal.
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2.
The effect of pH on citric acid cough challenge: A randomised control trial in chronic cough and healthy volunteers.
Rai, ZL, Fowles, HE, Wright, C, Howard, J, Morice, AH
Respiratory physiology & neurobiology. 2018;:51-54
Abstract
INTRODUCTION Citric acid has been used for over six decades to induce cough; however the mechanism of its pro-tussive effect is still not fully understood. We assessed the response to inhalation of citric acid at varying levels of acidity to determine if the pH of the solution plays a role in the induction of cough. Data was collected from both healthy volunteers and patients with chronic cough. METHODS 20 chronic cough patients and 20 healthy volunteers were recruited and underwent three cough challenges on separate days. Each visit involved 5 repeated one second inhalations of 300 mM citric acid solution. The concentration of the citrate cation remained constant, but the pH of the solution altered by the addition of sodium bicarbonate to 3, 5 and 6, representing the pKa values of the individual acid moieties. The total number of coughs elicited was recorded for each inhalation. RESULTS Two subjects withdrew and were not included in the analysis. Participants were gender matched, each group consisting of 12 females. 74% of chronic coughers coughed at pH 3 (mean coughs 16), 89% coughed at pH 5 (18) and 63% coughed at pH 6 (7). In healthy volunteers, 60% of subjects coughed at pH 3 (9), 30% of subjects coughed at pH 5 (3), and 10% of subjects coughed at pH 6 (0). Thus chronic cough patients coughed more than healthy volunteers and did not exhibit a clear pH concentration response. There was also a greater variability in their response to individual challenges.
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3.
[Micro-invasive embedding combined with montelukast sodium for children cough variant asthma:a randomized controlled trial].
Wang, X, Liu, B, Lu, B, Zhang, Y, Wang, L, Li, H, Han, X, Ding, D
Zhongguo zhen jiu = Chinese acupuncture & moxibustion. 2017;(3):259-264
Abstract
OBJECTIVE To observe the effects of micro-invasive embedding combined with montelukast sodium and simple montelukast sodium for children cough variant asthma (CVA). METHODS A total of 240 patients were randomly assigned into an observation group and a control group, 120 cases in each one. Considering of cases dropping, 101 patients in the observation group and 105 cases in the control group were included. Montelukast sodium chewable tablets were applied before sleep for 3 months in the control group, 5 mg a time, once a day. Based on the treatment as the control group, micro-invasive embedding was used for 3 months in the observation group, twice in the first month and once in the other two months. The acupoints were Feishu (BL 13), Danzhong (CV 17), Dingchuan (EX-B 1), and Zusanli (ST 36). Follow-up was conducted 9 months after treatment in the two groups. The cough score, serum immunoglobulin (IgE, IgG, IgA), platelet activating factor (PAF) were observed before and after treatment. The indices were compared before and after treatment and at follow-up, including pulmonary function indices[peak expiratory flow rate (PEF), forced expiratory volume at the 1st second (FEV1)], and small airway function indices[forced expiratory flow rate with remaining 25% vital capacity (MEF25%), forced expiratory flow rate with remaining 50% vital capacity (MEF50%), forced expiratory flow rate with remaining 75% vital capacity (MEF75%) and mid expiratory flow rate (MEF25%-75%)]. Also, the total effects were evaluated. RESULTS ①The total effective rate in the observation group was 93.1% (94/101), which was better than 87.6% (92/105) in the control group (P<0.05). The cough disappearance time of the cured children in the observation group was (10.38±2.64) d, and it was shorter than (10.72 ±2.60) d of those in the control group (P<0.05). After treatment, the cough score apparently decreased compared with those before treatment in the two groups (both P<0.05), with better result in the observation group (P<0.05). At follow-up, the recurrence frequency of the observation group was (1.43±1.20), and it was less than (1.91±1.71) in the control group (P<0.05). ②The levels of serum IgA and IgG after treatment in the two groups increased, and those of serum IgE and PAF decreased, compared with those before treatment. There was statistically significance except IgG in the control group before and after treatment (all P<0.05), with better Results in the observation group after treatment (all P<0.05). ③ Compared with those before treatment, all the pulmonary function indices were improved obviously after treatment and at follow-up in the two groups (all P<0.05), without statistically significance between the two groups (both P>0.05). ④ There was no statistically significance before and after treatment on small airway function indices in the two groups (all P>0.05). The indices at follow-up increased compared with those before treatment in the two groups (all P<0.05), with better Results in the observation group (all P<0.05). CONCLUSIONS Micro-invasive embedding combined with montelukast sodium achieved de-finite effect for children CVA, which can improve the body's immune and microcirculation. The effect is better than that of simple montelukast sodium on improving small airway function, etc.
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To evaluate the efficacy and safety of CofNovex plus (EMA) syrup.
Ali, Z, Daniyal, M, Adhia, MK, Alam, A, Sarfaraz, B, Sattar, A, Usmanghani, K
Pakistan journal of pharmaceutical sciences. 2017;(2(Suppl.)):591-596
Abstract
The cough and cold are very widespread conditions and a common purpose for advice in general practice. Utmost often the sign and symptoms of cough are produced by acute viral airway infection and the course is frequently benign. But it can be converted into bacterial super-infection and can cause acute bronchitis. Herbal medicines are used to treat symptoms of the cough and cold, and among these medicines Ivy leaf is used to treat mucous discharge and irritation in throat due to the cough and cold. In addition to synthetic substances such as acetylcysteine, carbocisteins, ambroxol and bromhexine, herbal medicines contain saponins, which are used in these indications. Not just Ivy, but also the marshmallow and mustard seeds used for these indications. This clinical trial was conducted in 220 patients, in which 110 receive the CofNovex plus European Medicines Agency (EMA) syrup and 110 receive the placebo. The age range of patients was 3 years to above 15 years. The sample paired t-test was applied to evaluate the significant level. CofNovex plus (EMA) syrup was very effective in treating cough and cold symptoms. The new treatment CofNovex plus (EMA) syrup was safe and well tolerated in patient at given specific age group.
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Effects of a novel sodium channel blocker, GSK2339345, in patients with refractory chronic cough
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Smith, JA, McGarvey, LPA, Badri, H, Satia, I, Warren, F, Siederer, S, Liefaard, L, Murdoch, RD, Povey, K, Marks-Konczalik, J
International journal of clinical pharmacology and therapeutics. 2017;(9):712-719
Abstract
OBJECTIVE Voltage-gated sodium channels (VGSC) are important in the initiation and propagation of action potentials in afferent sensory nerve fibers responsible for evoking cough. This study investigated the efficacy of GSK2339345, a VGSC inhibitor, in the treatment of refractory chronic cough (RCC). METHODS A three-part randomized, double-blind, placebo-controlled, cross-over study was conducted in the UK. In part A, patients with RCC received two inhaled doses of either GSK2339345 or placebo, 4 hours apart during three study periods. Patients were monitored for cough for 8 hours post-first dose using the VitaloJAK, ambulatory cough monitor. In parts B and C, patients underwent full dose-response cough challenges with capsaicin and citric acid respectively following single doses of randomly assigned GSK2339345 or placebo (4 study days). Part A was analyzed using a mixed effects model and parts B and C using population non-linear mixed effects models. RESULTS Of 16 enrolled patients, 11 completed the study. 8-hour cough counts increased following GSK2339345 treatment compared with placebo (GSK2339345/placebo ratio of adjusted geometric means: 1.26 (90% credible interval 1.10, 1.44), associated with GSK2339345-evoked coughing, recorded during the 2 minutes post-dose. This was not observed with placebo. The effect of GSK2339345 on cough responses during cough challenges was inconclusive. GSK2339345 was well tolerated. CONCLUSIONS While these data could not determine if GSK2339345 reached the target VGSC, they strongly suggest that GSK2339345 has no anti-tussive effect despite reaching airway sensory nerves as evidenced by the evoked transient cough.
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Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial.
Chamberlain Mitchell, SA, Garrod, R, Clark, L, Douiri, A, Parker, SM, Ellis, J, Fowler, SJ, Ludlow, S, Hull, JH, Chung, KF, et al
Thorax. 2017;(2):129-136
Abstract
BACKGROUND Physiotherapy, and speech and language therapy are emerging non-pharmacological treatments for refractory chronic cough. We aimed to investigate the efficacy of a physiotherapy, and speech and language therapy intervention (PSALTI) to improve health-related quality of life (HRQoL) and to reduce cough frequency in patients with refractory chronic cough. METHODS In this multicentre randomised controlled trial, patients with refractory chronic cough were randomised to four weekly 1:1 sessions of either PSALTI consisting of education, laryngeal hygiene and hydration, cough suppression techniques, breathing exercises and psychoeducational counselling or control intervention consisting of healthy lifestyle advice. We assessed the change in HRQoL at week 4 with the Leicester Cough Questionnaire (LCQ). Secondary efficacy outcomes included 24-hour objective cough frequency (Leicester Cough Monitor) and cough reflex sensitivity. The primary analysis used an analysis of covariance adjusted for baseline measurements with the intention-to-treat population. This study was registered at UK Clinical Research Network (UKCRN ID 10678). FINDINGS Between December 2011 and April 2014, we randomly assigned 75 participants who underwent baseline assessment (34 PSALTI and 41 controls). In the observed case analysis, HRQoL (LCQ) improved on average by 1.53 (95% CI 0.21 to 2.85) points more in PSALTI group than with control (p=0.024). Cough frequency decreased by 41% (95% CI 36% to 95%) in PSALTI group relative to control (p=0.030). The improvements within the PSALTI group were sustained up to 3 months. There was no significant difference between groups in the concentration of capsaicin causing five or more coughs. INTERPRETATION Greater improvements in HRQoL and cough frequency were observed with PSALTI intervention. Our findings support the use of PSALTI for patients with refractory chronic cough. TRIAL REGISTRATION NUMBER UKCRN ID 10678 and ISRCTN 73039760; Results.
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Efficacy and safety of Maekmoondong-tang for chronic dry cough: a study protocol for a randomized controlled trial.
Kim, KI, Shin, S, Kim, K, Lee, J
BMC complementary and alternative medicine. 2016;:46
Abstract
BACKGROUND Chronic cough, defined it lasts more than 8 weeks. The symptom is common, but highly troublesome, and it reduces quality of life. Despite much effort to develop a protocol for diagnosis and treatment of chronic cough, it remains problematic to determine its cause. As a result, treatment is often unsuccessful. Thus, there is much interest regarding the use of symptomatic drugs to control chronic cough. Maekmoondong-tang is widely used in East Asian countries to treat chronic dry cough. Several experimental studies have reported that the herbal medicine has immunomodulatory and antitussive effects. Clinical studies involving Maekmoondong-tang have also been carried out; however, these studies have involved treating various diseases as a whole rather than chronic cough itself. Thus, we aim to evaluate the efficacy and safety of Maekmoondong-tang in chronic dry cough patients with a randomized controlled trial. METHODS/DESIGN This study is designed as an exploratory, single-center, placebo-controlled, double-blind, randomized, parallel group clinical trial. Patients with dry cough that has lasted more than 8 weeks will be recruited, after a 1-week run-in period, and randomly allocated to either the Maekmoondong-tang treatment group or the placebo group. The patients will receive Maekmoondong-tang or placebo granules 3 times daily for 4 weeks, with a 2-week follow-up. The primary outcome is a 10-point cough diary that will be recorded on a daily basis. The secondary outcomes comprise a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), the Pattern Identification for Chronic Cough Questionnaire, biomarkers, safety testing, etc. Adverse events will also be reported. DISCUSSION This trial will assess the efficacy and safety of Maekmoondong-tang in chronic dry cough. TRIAL REGISTRATION Korean Clinical Trial Registry ( http://cris.nih.go.kr ; registration number: KCT0001646). Date of registration: October 5 2015.
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Use of honey associated with Ananas comosus (Bromelin) in the treatment of acute irritative cough.
Peixoto, DM, Rizzo, JA, Schor, D, Silva, AR, Oliveira, DC, Solé, D, Sarinho, E
Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo. 2016;(4):412-417
Abstract
OBJECTIVE To evaluate the immediate improvement rate of irritative cough in patients treated with the combination of Ananas comosus extract and honey (Bromelin®) compared with the use of honey alone (placebo group). METHODS Pragmatic, double-blind, randomized, parallel-group study with children aged between 2 and 15 years, with irritative cough for at least 24hours. The double-blind assessment of cough was through the number of observed coughing episodes and intensity score for a period of 10minutes of observation. The decrease of one point in the mean total score was considered as a therapeutic effect. RESULTS There was a reduction in coughing episodes in both groups, as well as in the cough score after 30minutes of drug or honey administration. The change in clinical score above two points, which could indicate marked improvement, occurred in five patients in the bromelin group and only in one in the placebo group, but without significant difference. There were no adverse events. CONCLUSIONS The immediate improvement rate of irritative cough was similar in patients treated with combination of Ananas comosus extract and honey (Bromelin®) compared with the use of honey alone (placebo group). It is possible that honey has a therapeutic effect on mucus and cough characteristics (Clinical Trials: NCT01356693).
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Intracuff 160 mg alkalinized lidocaine reduces cough upon emergence from N2O-free general anesthesia: a randomized controlled trial.
Souissi, H, Fréchette, Y, Murza, A, Masse, MH, Marsault, É, Sarret, P, D'Aragon, F, Parent, AJ, Sansoucy, Y
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2016;(7):862-70
Abstract
PURPOSE Chemical and mechanical irritation of the tracheal mucosa influences the incidence of cough at emergence from general anesthesia, potentially leading to significant postoperative complications. This study evaluates the benefits of endotracheal tube (ETT) intracuff alkalinized lidocaine during N2O-free general anesthesia by 1) assessing the in vitro effect of alkalinization on lidocaine diffusion kinetics across the cuff's membrane and 2) evaluating, in a randomized controlled clinical trial, the impact of 160 mg of intracuff alkalinized lidocaine on cough upon emergence from anesthesia for surgery lasting > 120 min. METHODS In the in vitro study, diffusion kinetics of various intracuff alkalinized lidocaine amounts (40, 80, and 160 mg) were compared to their non-alkalinized lidocaine controls. In the clinical trial, 80 adult patients (American Society of Anesthesiologists physical status I-III) undergoing urological or gynecological surgery expected to last > 120 min and scheduled for N2O-free general anesthesia were enrolled. The ETT cuffs (high-volume, low-pressure) were filled with either 160 mg of alkalinized lidocaine or a comparable volume of 0.9% saline. The primary outcome was the incidence of cough upon emergence from anesthesia. Sore throat, hoarseness, and postoperative nausea and vomiting were evaluated as secondary outcomes. RESULTS Our in vitro study confirmed that alkalinization increases lidocaine diffusion across the membrane of ETT cuffs and suggested that the lidocaine diffusion rate is associated with the initial intracuff lidocaine quantity. Our clinical trial demonstrated that, compared with the saline group, 160 mg of intracuff alkalinized lidocaine reduced the incidence of cough upon emergence from N2O-free general anesthesia (76% vs 34%, respectively; difference 42%; 95% confidence interval, 21% to 62%; P < 0.001) while having no clinical impact on secondary outcomes. CONCLUSIONS The use of 160 mg of intracuff alkalinized lidocaine is associated with a decreased incidence of cough upon emergence from N2O-free general anesthesia > 120 min. This trial was registered at www.clinicaltrials.gov (NCT01774292).
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Efficacy of add-on montelukast in nonasthmatic eosinophilic bronchitis: the additive effect on airway inflammation, cough and life quality.
Bao, W, Liu, P, Qiu, Z, Yu, L, Hang, J, Gao, X, Zhou, X
Chinese medical journal. 2015;(1):39-45
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Abstract
BACKGROUND The efficacy of montelukast (MONT), a cysteinyl leukotriene receptor antagonist, in nonasthmatic eosinophilic bronchitis (NAEB), especially its influence on cough associated life quality is still indefinite. We evaluated the efficacy of MONT combined with budesonide (BUD) as compared to BUD monotherapy in improving life quality, suppressing airway eosinophilia and cough remission in NAEB. METHODS A prospective, open-labeled, multicenter, randomized controlled trial was conducted. Patients with NAEB (aged 18-75 years) were randomized to inhaled BUD (200 μg, bid) or BUD plus oral MONT (10 μg, qn) for 4 weeks. Leicester cough questionnaire (LCQ) life quality scores, cough visual analog scale (CVAS) scores, eosinophil differential ratio (Eos), and eosinophil cationic protein (ECP) in induced sputum were monitored and compared. RESULTS The control and MONT groups contained 33 and 32 patients, respectively, with similar baseline characteristics. Significant with-in group improvement in CVAS, LCQ scores, Eos, and ECP was observed in both groups during treatment. After 2-week treatment, add-on treatment of MONT was significantly more effective than BUD monotherapy for CVAS decrease and LCQ scores improvement (both P < 0.05). Similar results were seen at 4-week assessment (both P < 0.05). 4-week add-on therapy of MONT also resulted in a higher percentage of patients with normal sputum Eos (<2.5%) and greater decrease of ECP (both P < 0.05). CONCLUSIONS MONT combined with BUD was demonstrated cooperative effects in improvement of life quality, suppression of eosinophilic inflammation, and cough remission in patients with NAEB.