Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT®)

Janssens, Wim; Liu, Yanping; Liu, Danfeng; Kesten, Steven; Tashkin, Donald P.; Celli, Bartolomé R.; Decramer, Marc

doi:10.1016/j.rmed.2013.04.015

Cited by 15 publications

(10 citation statements)

References 18 publications

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“…A significant improvement in FEV 1 of 66 ± 120 ml (p= 0.01) was observed in the roflumilast group compared to baseline. The response was driven by a subset of responders (n = 8) with a change in FEV 1 exceeding the measurement error of FEV 1 recently determined to be 120 ml (37). The responders experienced greater dynamic hyperinflation during exercise at baseline compared to the non-responders as determined by the Borg fatigue score.…”

Section: Resultsmentioning

confidence: 99%

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Hendeles

Daley‐Yates

Hermann³

et al. 2015

AAPS J

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In the session on "Pharmacodynamic studies to demonstrate efficacy and safety", presentations were made on methods of evaluating airway deposition of inhaled corticosteroids and bronchodilators, and systemic exposure indirectly using pharmacodynamic study designs. For inhaled corticosteroids, limitations of measuring exhaled nitric oxide and airway responsiveness to adenosine for anti-inflammatory effects were identified, whilst measurement of 18-h area under the cortisol concentration-time curve was recommended for determining equivalent systemic exposure. For bronchodilators, methacholine challenge was recommended as the most sensitive method of determining the relative amount of β-agonist or anti-muscarinic agent delivered to the airways. Whilst some agencies, such as the Food and Drug Administration (FDA), do not require measuring systemic effects when pharmacokinetic measurements are feasible, the European Medicines Agency requires measurement of heart rate and serum potassium, and some require serial electrocardiograms when bioequivalence is not established by pharmacokinetic (PK) studies. The Panel Discussion focused on whether PK would be the most sensitive marker of bioequivalence. Furthermore, there was much discussion about the FDA draft guidance for generic fluticasone propionate/salmeterol. The opinion was expressed that the study design is not capable of detecting a non-equivalent product and would require an unfeasibly large sample size.

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Section: Resultsmentioning

confidence: 99%

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Hendeles

Daley‐Yates

Hermann³

et al. 2015

AAPS J

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“…Previous reports have indicated the potential of telemedicine to enhance both quality and diagnostic potential of spirometry testing carried out by nonexpert professionals [ 13 - 15 ], but the quality control in those studies was based on offline analyses by expert professionals carried out in a time consuming manner [ 16 - 18 ]. Likewise, the need for an external, likely centralized, quality control program [ 15 , 17 - 20 ] is well established.…”

Section: Discussionmentioning

confidence: 99%

Clinical Decision Support System to Enhance Quality Control of Spirometry Using Information and Communication Technologies

Burgos¹,

Melia²,

Vallverdú³

et al. 2014

JMIR Med Inform

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BackgroundWe recently demonstrated that quality of spirometry in primary care could markedly improve with remote offline support from specialized professionals. It is hypothesized that implementation of automatic online assessment of quality of spirometry using information and communication technologies may significantly enhance the potential for extensive deployment of a high quality spirometry program in integrated care settings.ObjectiveThe objective of the study was to elaborate and validate a Clinical Decision Support System (CDSS) for automatic online quality assessment of spirometry.MethodsThe CDSS was done through a three step process including: (1) identification of optimal sampling frequency; (2) iterations to build-up an initial version using the 24 standard spirometry curves recommended by the American Thoracic Society; and (3) iterations to refine the CDSS using 270 curves from 90 patients. In each of these steps the results were checked against one expert. Finally, 778 spirometry curves from 291 patients were analyzed for validation purposes.ResultsThe CDSS generated appropriate online classification and certification in 685/778 (88.1%) of spirometry testing, with 96% sensitivity and 95% specificity.ConclusionsConsequently, only 93/778 (11.9%) of spirometry testing required offline remote classification by an expert, indicating a potential positive role of the CDSS in the deployment of a high quality spirometry program in an integrated care setting.

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“…The strengths of the present analysis include the large number of patients with varying degrees of severity of airflow obstruction who were followed over an extended period of time, the high quality and reproducibility of spirometry [ 14 ] and the relatively large doses of the two different classes of short-acting bronchodilators that were administered along with the timing of post-bronchodilator spirometry to coincide with the time of expected peak action of each class of bronchodilator.…”

Section: Discussionmentioning

confidence: 99%

“…Briefly, as part of this trial, pre- and post-bronchodilator spirometry was performed in accordance with American Thoracic Society guidelines [ 13 ] at baseline and 1 month and every 6 months following randomization over 4 years. Identical spirometric equipment and study-specific software were used at each site with central quality-assurance review of all spirometry data throughout the trial [ 12 , 14 ]. At each visit, immediately following the pre-bronchodilator spirometry, patients received study drug (either tiotropium or placebo) followed by 4 inhalations of ipratropium, 18 μg/inhalation, followed 1 hour later by 4 inhalations of albuterol, 100 μg/inhalation, followed 30 min later by spirometry again.…”

Section: Methodsmentioning

confidence: 99%

Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD

Tashkin

Kleerup

et al. 2014

Respir Res

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Background: We previously reported a progressive decline in absolute responses of FEV 1 and FVC to a near-maximal dose of 2 different short-acting bronchodilators over 4 years. Since varying host factors and the method of expressing the response may impact the time trend of acute bronchodilator responses, we now examined the potential influence of salient host characteristics on changes in bronchodilator responses over time expressed in different ways.

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Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT®)

Abstract: NCT00144339.

Cited by 15 publications

References 18 publications

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Pharmacodynamic Studies to Demonstrate Bioequivalence of Oral Inhalation Products

Clinical Decision Support System to Enhance Quality Control of Spirometry Using Information and Communication Technologies

Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD

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