Trial reportJournal of aerosol medicine and pulmonary drug delivery2010
Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients.
Trial report in Journal of aerosol medicine and pulmonary drug delivery, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04421742 (The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study), which is not on this map. Cited by 56 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study (IOSCOPD20161102)
Who cites it
56 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Lung Deposition and Inspiratory Flow Rate in Patients with Chronic Obstructive Pulmonary Disease Using Different Inhalation Devices: A Systematic Literature Review and Expert Opinion.International journal of chronic obstructive pulmonary diseasePooled it
- Changes in ventilation-perfusion during and after an COPD exacerbation: an assessment using fluid dynamic modeling.International journal of chronic obstructive pulmonary disease · 2018Trial
- SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study.Pharmaceutical research · 2017Trial
- Functional respiratory imaging to assess the interaction between systemic roflumilast and inhaled ICS/LABA/LAMA.International journal of chronic obstructive pulmonary disease · 2016Trial
- 1-year prospective real life monitoring of asthma control and quality of life in Italy.Respiratory research · 2012Trial
- Effect of AeroChamber Plus™ on the lung and systemic bioavailability of beclometasone dipropionate/formoterol pMDI.British journal of clinical pharmacology · 2011Trial
- Effects of beclomethasone/formoterol fixed combination on lung hyperinflation and dyspnea in COPD patients.International journal of chronic obstructive pulmonary disease · 2011Trial
- Systemic exposure and implications for lung deposition with an extra-fine hydrofluoroalkane beclometasone dipropionate/formoterol fixed combination.Clinical pharmacokinetics · 2009Trial
- Optimizing Respiratory Care with NEXThaler: Bridging Technology and Treatment.Medical devices (Auckland, N.Z.) · 2026Review
- Interpreting respiratory oscillometry in adults with asthma or COPD: findings of an international Delphi study.ERJ open research · 2025Article
- Regulatory and Industry Perspective on the Model Master File Framework for Locally Acting Drug Products.Pharmaceutical research · 2025Article
- Non-local impact of distal airway constrictions on patterns of inhaled particle deposition.Royal Society open science · 2024Article
- Article
- The effects of airway disease on the deposition of inhaled drugs.Expert opinion on drug delivery · 2024Review
- Modelling Drug Delivery to the Small Airways: Optimization Using Response Surface Methodology.Pharmaceutical research · 2024Article
- Small airway dysfunction measured by impulse oscillometry is associated with exacerbations and poor symptom control in patients with asthma treated in a tertiary hospital subspecialist airways disease clinic.Frontiers in allergy · 2024Article
- Modeled small airways lung deposition of two fixed-dose triple therapy combinations assessed with in silico functional respiratory imaging.Respiratory research · 2023Article
- Lung Deposition of Inhaled Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide in Healthy Volunteers and Asthma: The STORM Study.Journal of aerosol medicine and pulmonary drug delivery · 2022Article
- Assessment of Symptoms Control, Pulmonary Function and Related Quality of Life in Asthmatic Patients Treated with Extrafine Beclomethasone Dipropionate/Formoterol Fumarate 100/6 μg pMDI: Results of a Multicenter Observational Study in Romania (ALFRESCO Study).Journal of asthma and allergy · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhen inhaling medication, it is essential that drug particles are delivered to all sites of lung inflammation, including the peripheral airways. The aim of this study was to assess the lung deposition and lung distribution of beclomethasone dipropionate (BDP)/formoterol (100/6 microg), both dissolved in hydrofluoroalkane (HFA) and delivered by pressurized metered dose inhaler (pMDI) in healthy subjects, asthmatic, and chronic obstructive pulmonary disease (COPD) patients, to investigate how the in vitro characteristics of the formulation translate into the in vivo performance in diseases with different airway obstruction.
methodsHealthy volunteers (n = 8), persistent asthmatics (n = 8), and patients with stable COPD (n = 8) completed this open-label, single-dose parallel-group study. Each patient received one single treatment of four puffs of (99 m)Tc-labeled BDP/formoterol formulation. The correlation between particle size distribution of radioactivity and of the drugs in the radiolabeled formulation was validated. Intra- and extrapulmonary deposition, amount of exhaled drug, and the central to peripheral ratio (C/P) were calculated immediately after inhalation. Patients' lung function and pharmacokinetic parameters were also assessed up to 24 h post-dose.
resultsThe average lung deposition of BDP/formoterol was 34.08 +/- 9.30% (relative to nominal dose) in healthy subjects, 30.86 +/- 8.89% in asthmatics, and 33.10 +/- 8.90% in COPD patients. Extrathoracic deposition was 53.48% +/- 8.95, 57.64% +/- 9.92 and 54.98% +/- 7.01, respectively. C/P ratios of 1.42 +/- 0.32 in healthy subjects, 1.96 +/- 0.43 in asthmatics, and 1.94 +/- 0.69 for COPD patients confirmed drug distribution to all regions of the lungs. Forced expiratory volume in 1 sec (FEV(1)) increased in all groups after BDP/formoterol inhalation, but was more evident in the patient groups. No significant correlation between baseline lung function and drug deposition was observed. Formoterol, BDP, and beclomethasone 17 monopropionate (B17MP) plasma profiles were comparable between groups.
conclusionInhalation of BDP/formoterol HFA (100/6 microg) produces high and homogeneous deposition of BDP and formoterol in the airways, regardless of pathophysiological condition.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.