Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis

Bilton, Diana; Bellon, G.; Charlton, Brett; Cooper, Peter; Boeck, K. De; Flume, Patrick A.; Fox, Howard; Gallagher, Charles G.; Geller, David E.; Haarman, Eric G.; Hebestreit, Helge; Kolbe, John; Lapey, Allen; Robinson, Phil; Wu, Jian; Zuckerman, Jonathan B.; Aitken, Moira L.

doi:10.1016/j.jcf.2012.11.002

Cited by 65 publications

(47 citation statements)

References 27 publications

(37 reference statements)

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“…Interestingly, in the pooled analysis, significant improvements in the mannitol versus control group in FEV 1 occurred in patients aged ≥18 years old but not in younger participants [14]. Furthermore, and similar to the current study, improvements in percent-predicted FEV 1 were observed in the placebo group in the 6-17-year age group [14], raising the question of whether more intense pulmonary function testing should be done as a run-in phase in children and adolescents (≤18 years) with CF.…”

Section: Discussionmentioning

confidence: 86%

“…In a recent study of inhaled mannitol, a sustained, significant (p<0.001) improvement in FEV 1 was seen in the control group [12], but the improvement was not significant in another similarly designed study (p=0.059) in similar populations [13]. Interestingly, in the pooled analysis, significant improvements in the mannitol versus control group in FEV 1 occurred in patients aged ≥18 years old but not in younger participants [14]. Furthermore, and similar to the current study, improvements in percent-predicted FEV 1 were observed in the placebo group in the 6-17-year age group [14], raising the question of whether more intense pulmonary function testing should be done as a run-in phase in children and adolescents (≤18 years) with CF.…”

Section: Discussionmentioning

confidence: 93%

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Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

Ratjen

Koker

Geller

et al. 2015

Journal of Cystic Fibrosis

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 93%

Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

Ratjen

Koker

Geller

et al. 2015

Journal of Cystic Fibrosis

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“…The pooled data from both studies indicated efficacy regardless of DNase use in both improving lung function and reducing exacerbations [26]. However, the effect size was greatest in adults rather than children.…”

Section: Hyperosmolar Therapymentioning

confidence: 99%

Inhaled Interventions in Cystic Fibrosis: Mucoactive and Antibiotic Therapies

Hurt¹,

Bilton²

2014

Respiration

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Treatment of cystic fibrosis lung disease has developed from an understanding of the abnormal airway surface liquid resulting from a lack of function of the cystic fibrosis transmembrane regulator protein. Mucus plugging resulting in infection and inflammation leads to airway wall destruction and bronchiectasis. Inhaled therapies have formed the backbone of treatments. In combination with antibiotics delivered direct to the airway, mucoactive drugs, including mucolytics and hyperosmolar agents, are utilised to improve mucociliary clearance to reduce infection and inflammation. Until recently, airway therapies were delivered as nebulisers, but we have now entered the era of dry powder inhalers for treatment of cystic fibrosis lung disease. The theory and practice of these therapies are discussed in this review.

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“…This will increase the volume of the airway surface liquid and improves mucociliary clearance [115][116][117]. To date, two long-term trials (26 weeks) investigated the efficacy and safety of inhaled dry powder mannitol in CF patients [115,116] and a third long-term trial is running (NCT02134353).…”

Section: Mannitolmentioning

confidence: 99%

Bronchial Hyperreactivity Related to Inhalation Therapy in Cystic Fibrosis Patients

Eyns¹

2014

J Pulm Respir Med

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It is presumed that bronchial hyperreactivity (BHR) can occur with any inhaled agent and may be a reason for discontinuation of inhalation therapy in cystic fibrosis (CF) patients. On the other hand, inhalation of antibiotics is being increasingly used to eradicate or treat infections.This review focuses on identifying the mechanisms of BHR for a better understanding of its impact on inhalation treatment. BHR in CF is suggested to be secondary to underlying airway disease (associated to poor pulmonary function, chronic inflammation and aerosol distribution) or to be a separate condition occurring more in CF. Furthermore, certain characteristics of the aerosol solution itself, such as the active molecule, chemical additives and particle size, can cause BHR.Recombinant human DNase (rhDNase), hypertonic saline (HS) and the antibiotics tobramycin, colistin and aztreonam lysine for inhalation (AZLI) are frequently used inhalation drugs in the treatment of CF. Prevalence of BHR related to both short and long-term inhalation of these drugs as reported in the literature was investigated. Acute BHR is documented in up to two thirds of CF patients. Despite the widespread use of rhDNase, HS, tobramycin, colistin and AZLI, only one long-term trial looked for, but did not demonstrate, BHR at the end of the trial period.

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Pooled analysis of two large randomised phase III inhaled mannitol studies in cystic fibrosis

Abstract: Sustained six-month improvements in lung function and decreased pulmonary exacerbation incidence indicate that inhaled mannitol is an important additional drug in the treatment of CF.

Cited by 65 publications

References 27 publications

Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

Tiotropium Respimat® in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials

Inhaled Interventions in Cystic Fibrosis: Mucoactive and Antibiotic Therapies

Bronchial Hyperreactivity Related to Inhalation Therapy in Cystic Fibrosis Patients

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