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Clickhaler (Clickhaler)

✓ Approved

Vectura Group Ltd · therapeutic agent

What is Clickhaler?

Clickhaler is a therapeutic agent developed by Vectura Group Ltd. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand NamesClickhaler
CompanyVectura Group Ltd
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Vectura Group Ltd

Therapeutic Indications

Clickhaler is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresOral appliance application✓ Approved

Related Research Articles

PubMedWest African journal of medicine2023-09-28

Effect of Chronic Obstructive Pulmonary Disease Severity on Inspiratory Flow Rates via Inhaler Devices.

Adetiloye A O AO, Akor A A AA, Awopeju O F OF, Adewole O O OO et al.

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disorder that affects millions of people worldwide and inhalation therapy is central to the symptomatic management of the disease. Therefore, knowledge of the minimum Peak inspiratory flow (PIF) requirements for specific inhalers especially dry powder inhalers (DPI's) is necessary when prescribing inhalation therapy. The purpose of this study is to assess the effect of COPD severity on PIF in patients with COPD. A total of 150 subjects (75 patients with stable COPD, and 75 apparently healthy subjects) participated in the study. PIF was assessed using the In-check Inhaler Assessment Kit (manufactured by Clement Clarke International Ltd, Harlow, UK). Lung function was assessed by spirometry with subjects divided into four groups based on the severity of their airway obstruction using the GOLD criteria. The Modified Medical Research Council (MMRC) dyspnea scale was used to assess dyspnea severity. Exercise capacity was assessed using the 6-minute walk test. Statistical analysis was performed with SPSS 23.0 software. In all the statistical tests, a p value of <0.05 was considered significant. The mean age for the COPD patient and control population are 72.48 ± 8.01 and 70.69 ± 5.82 respectively. The control group had higher PIF than COPD group; however, only the clickhler and pMDI had statistically significant difference between the mean PIF of the patients compared with the control group. Generally, there was an observed trend of a decrease in mean PIF as the COPD stage progresses with a statistically significant difference observed for Easibreathe (F= 3.52, p= 0.019) and pressurized Metered dose inhaler (pMDI) (F= 4.26, p= 0.008). There was a significant positive correlation between FEV1%, FVC, Exercise capacity (6-minute walk distance) and PIF for Clickhaler, Autohaler, Easybreathe and pMDI. For pMDI, there was a statistically significant difference between means of PIF across the MMRC dyspnea scale with PIF decreasing with increasing severity of dyspnea (F= 2.85, p= 0.033). COPD patients have slightly lower PIF than controls. Poor exercise tolerance and lower spirometric pulmonary function parameters may contribute to low PIF.

PMID 37768327
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PubMedWest African journal of medicine2023-05-29

Determinants of Suboptimal Peak Inspiratory Flow Rates among Patients with Chronic Obstructive Pulmonary Disease in Southwest, Nigeria.

Arawomo A O AO, Erhabor G E GE, Tanimowo M O MO, Awopeju O F OF et al.

Inhalational therapy is the cornerstone in the management of chronic obstructive pulmonary disease (COPD) patients. Patients' peak inspiratory flow impacts effective dry powder inhaler (DPI) delivery and management outcome. This study assessed peak inspiratory flow rates (PIFR) and determined the factors associated with suboptimal inspiratory flow rates among COPD patients. A descriptive cross-sectional study was conducted among 60 participants (30 stable COPD patients and 30 age-and-sex matched controls). Socio-demographic characteristics was obtained and spirometry was done for all participants. PIFR assessment was done using the In-Check Dial Meter and was categorized as suboptimal (< 60L/min) or optimal (≥ 60L/min). P values less than 0.05 were taken as statistically significant. Mean age of the COPD patients and healthy controls were both 67.8 ± 10.3 years, with 53.3% being females. Post-bronchodilation FEV 1/FVC% for COPD patients was 54.15 ± 11.27%. The mean PIFR among COPD patients was significantly lower than that of healthy controls, in all DPIs simulated, especially for Clickhaler (46.2±13.4 vs 60.5±11.4L/min, p<0.001). A significant proportion of COPD patients had suboptimal PIFR, in the simulated resistances against Clickhaler and Turbuhaler (70% vs 80%; p<0.001). Older age, shorter height and low BMI were associated with suboptimal PIFR among COPD patients. However, independent predictors of suboptimal PIFR were BMI, PEFR, FEV1% and FVC%. Suboptimal PIFR was found in a significant number of COPD patients when compared with healthy respondents. Routine assessment using In-Check Dial meter should be done to determine the suitability of dry powder inhalers for patients with COPD.

PMID 37247343
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PubMedPloS one2018-02-21

Assessment of inhalation flow patterns of soft mist inhaler co-prescribed with dry powder inhaler using inspiratory flow meter for multi inhalation devices.

Hira Daiki D, Koide Hiroyoshi H, Nakamura Shigemi S, Okada Toyoko T et al.

The patients' inhalation flow pattern is one of the significant determinants for clinical performance of inhalation therapy. However, the development of inhalation flow meters for various inhalation devices has been unable to keep up with the increasing number of newly launched inhalation devices. In the present study, we developed simple attachment orifices for the inhalation flow pattern monitoring system, which are suitable for all commercial inhalers, and investigated the efficacy of the system on the clinical inhalation instruction for patients co-prescribed dry powder inhaler (DPI) and soft mist inhaler (SMI). First, we constructed simple attachment orifices that were adjusted for 13 commercial inhalers, and examined the correlation between orifice and inhalation device. Second, the inhalation flow patterns (peak inspiratory flow rate, PIFR; inhalation duration time, DT) of patients prescribed a combination of DPI and SMI were monitored before and after inhalation instruction. The inhalation resistance of commercial inhalers are listed in the following order; Twincaps® > Handihaler® > Swinghaler® = Clickhaler® > Twisthaler® > Turbuhaler® > Jenuair® > Diskus® = Ellipta® > Diskhaler® > Breezhaler® > Respimat® = pMDI. The pressure drop via orifice was significantly correlated with that via the commercial inhaler. For the confirmation, all participants achieved the DPI criterion of PIFR. On the other hand, 4 participants (6 clinical visits) of 10 experimented participants could not achieve the essential criterion of DT (> 1.5 sec) for SMI, but all participants improved their duration time after inhalation instruction by pharmacists (P<0.05). In the present study, we successfully developed simple attachment orifice suitable for 13 commercial inhalation devices. These data suggested that our simple attachment orifices for the inhalation flow pattern monitoring system can detect patients with inadequate inhalation patterns via SMI.

PMID 29462195
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PubMedInternational journal of pharmaceutics2013-07-31

Aerodynamic dose emission characteristics of dry powder inhalers using an Andersen Cascade Impactor with a mixing inlet: the influence of flow and volume.

Yakubu Sani Ibn SI, Assi Khaled H KH, Chrystyn Henry H

An interaction between device resistance and inhalation flow provides the 'energy' to de-aggregate the metered dose of dry powder inhalers (DPIs). Hence all dry powder inhalers demonstrate flow dependent dose emission but information on this at low flows is not available. We have adapted the compendial method for the Andersen Cascade Impactor (ACI) to include a mixing inlet to determine the aerodynamic dose emission characteristics of a salbutamol Diskus(®) [DSK], Easyhaler(®) [EASY] and Clickhaler(®) [CLICK] and the terbutaline Turbuhaler(®) [TBH] using flows of 10-60 L/min and inhalation volumes of 2 and 4 L. All DPIs demonstrated flow dependent dose emission (p<0.001) but there was no difference in the measurements between 2 and 4 L. The flow dependent dose emission properties of each DPI started to plateau when the pressure change inside each device, during an inhalation, was between 1 and 1.5 kPa. This corresponds to inhalation flows of 40.1-49.1, 25.4-28.9, 23.6-28.9 and 29.7-36.3 L/min through DSK, CLICK, EASY and TBH. The adapted methodology allows measurements at low flows. The results highlight that the compendial methodology to use an inhaled volume of 4 L with the ACI could be replaced by 2 L and that the recommendation to make measurements using a pressure drop of 4kPa should be revised.

PMID 23892154
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PubMedArerugi = [Allergy]2010-09-08

[The relationship between inspiratory pressure and flow through dry powder inhaler available in Japan].

Kondo Tetsuri T, Tanigaki Toshimori T, Tazaki Gen G, Watanabe Hidehiro H et al.

Recently many of the inhaled drugs are provided as dry powder formula and prescribed for such diseases as COPD and asthma exacerbation. Inspiratory flow rate through the dry powder device (DPI) has a significant influence on therapeutic response in these disease conditions. We planned to measure flow vs. pressure relationships of almost all of the DPIs available in Japan. Driving pressure (PI) and flow through the DPI were measured and the linear regression lines between PI and flow(2) were drawn. The slope and intercept of the regression lines were as follows: Turbuhaler for Pulmicort 79.26 (l/s)(2)/cmH2O, 626 (l/s)(2), Turbuhaler for Symbicort 88.99, 688, Twisthaler 56.37, 478, Diskus 125.98, 872, Diskhaler, 166.98, 780, Handihaler, 54.88, 498, Clickhaler, 78.37, 452. We drew P(I) vs flow curves of each DPIs for instruction of DPI devices to the patients. Inspiratory pressure is an excellent parameter to indicate optimal flow through DPI. Early escalation of medication may be important in the patients using Turbuhaler or Twisthaler that has higher resistance in inspiratory channel.

PMID 20820136
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PubMedJournal of aerosol medicine and pulmonary drug delivery2008-10-01

Handling of and preferences for available dry powder inhaler systems by patients with asthma and COPD.

Schulte Martina M, Osseiran Karim K, Betz Reiner R, Wencker Marion M et al.

The correct handling of dry powder inhalers (DPIs) is crucial for efficient therapy, and acceptance of the device can improve compliance. The handling of seven different dry powder inhalers was studied in 72 patients with asthma and chronic obstructive pulmonary disease (COPD). The aim of this study was to identify possible handling errors and investigate patient preferences. Patients inhaled twice with each inhaler; first after reading the device leaflet, and second after device handling was explained by the investigator. The investigator identified handling errors and critical handling errors, which might lead to insufficient or no dose delivery. Afterward, the patients selected their preferred device and judged different aspects of device handling. The lowest number of patients with critical handling errors was observed for the Diskus/Accuhaler, the highest numbers for the Jethaler and the Easyhaler (% of patients during first/second use): Diskus/Accuhaler 25%/13.9% (group A) and 38.9%/8.3% (group B); Clickhaler 50.0%/52.8%, Cyclohaler 58.3%/13.9%, Jethaler 66.7%/30.6% (group A) and Benosid N Inhaler 52.8%/22.2%, Novolizer 52.8%/25.0%, Easyhaler 72.2%/47.2% (group B). Device handling improved after instruction by the investigator. Device handling and preferences of patients closely correlated in this study. Both devices producing the lowest numbers of handling errors (Diskus/Accuhaler and Clickhaler) had the highest preference by the subjects (score from 1 = very good to 7 = very bad): Diskus/Accuhaler 2.21 (group A) and 2.02 (group B); Clickhaler 2.21, Cyclohaler 2.80, Jethaler 3.16 (group A); Novolizer 2.33, Easyhaler 2.37, Benosid N Inhaler 2.43 (group B). Critical handling errors may reduce therapy outcome due to a reduced dose delivery. In addition, reduced patients acceptance of a device, being dependent on device handling, may have a similar effect by reducing patients' compliance.

PMID 18823257
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