Nebuhaler versus wet aerosol for domiciliary bronchodilator therapy: A multi‐centre clinical comparison
Robert J. PierceChristine F. McDonaldLouis I. LandauPeter N. Le SouëfJohn G. ArmstrongCharles MitchellPaul W. FrancisAndrew MartinArthur W. MuskRal AnticElizabeth ClarkElizabeth Ryder
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Abstract:
Objective To compare the clinical effectiveness and patient acceptance of a large spacer device (Nebuhaler™) for delivery of metered dose aerosol (MDI) terbutaline with nebulised wet aerosol terbutaline. Design Randomised open crossover study over two sequential four week treatment periods, following a two week run-in. Setting Multi-centre including five adult thoracic units and three paediatric centres throughout Australia. Patients Thirty-eight adults and 23 children with clinical asthma and reversible airflow obstruction (increase in forced expiratory volume in one second [FEV1] of ≥15% in response to inhaled bronchodilator) entered the study proper. Six adults and one child withdrew. Interventions Terbutaline was administered four times dialy via Nebuhaler/MDI or nebuliser. Clinical assessment with spirometry and peak flow readings was made after run-in and at the end of each treatment period. Patients recorded on diary cards daily peak expiratory flow rates and symptom scores and comparisons of these results for each treatment period were made. At the completion of the study patients answered a treatment preference questionnaire. Results No differences were found between the two treatment periods in diary card peak flow recordings and symptom score data, and in clinical assessment of spirometry and peak expiratory flow rates. There were also no differences between spirometry and peak flow values recorded at the clinic at randomisation and at the end of each treatment period, suggesting stable basal airflow obstruction over the period of the study. Thirty-two per cent of adults and 52% of children preferred the Nebuhaler/MDI combination, mainly because of convenience of use. Treatment preference was not related to any measured index of lung function. Conclusions MDI terbutaline delivered via Nebuhaler provides clinical benefit similar to that of wet aerosol terbutaline in the long-term domiciliary management of patients with stable airflow obstruction.Keywords:
Terbutaline
Peak flow meter
Crossover study
Terbutaline
Bronchodilatation
Bronchodilator Agents
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Eight patients with chronic severe asthma, poorly controlled by conventional doses of inhaled bronchodilator, were treated with high-dose inhaled terbutaline (4 mg four times daily), via either wet nebulisation of terbutaline respirator solution, or by tube-spacer aerosol, using cannisters delivering 1 mg terbutaline per metered dose. All patients improved objectively and subjectively on these higher dosage regimens during both day and night. A trial of high-dose inhaled beta2 sympathomimetic therapy should be considered in any patient with chronic severe asthma who fails to obtain benefit from standard doses of inhaled bronchodilator.
Terbutaline
Bronchodilator Agents
Metered-dose inhaler
Nebulizer
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Terbutaline
Bronchodilatation
Bronchodilator Agents
Onset of action
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BACKGROUND: Controversy exists regarding the best method to interpret pediatric spirometry. There is also controversy regarding the benefit of performing post-bronchodilator spirometry after normal baseline spirometry. This study compares the use of lower limit of normal (LLN) against percent of predicted (PP) in the interpretation of spirometry. We also investigate the occurrence of a substantial bronchodilator response for patients who received post-bronchodilator spirometry. METHODS: Spirometric tests performed in the pediatric clinic at San Antonio Military Medical Center were retrospectively reviewed. Results of spirometry were compared using LLN and PP for interpretation. Abnormal spirometry was defined as a low FEV 1 or low FEV1/FVC, indicating evidence of airway obstruction. The presence of a substantial bronchodilator response was recorded and the results were analyzed. RESULTS: Of 242 tests, 212 normal and 30 abnormal tests were reported using the LLN interpretation strategy. Using the PP interpretation strategy, there was a significant difference in the number of normal (183) and abnormal (59) tests, when compared to the LLN (P < .001). No significant difference between LLN versus PP interpretation strategies was noted in the number of baseline tests, normal or abnormal, that demonstrated a substantial response to bronchodilator. Of the subjects with normal baseline spirometry, 10% (PP) and 12% (LLN) had a substantial bronchodilator response. An abnormal baseline spirometry was more likely to have a substantial response to bronchodilator, compared to normal baseline spirometry (P < .001). CONCLUSIONS: The use of LLN for interpretation is more likely to report a test as normal, when compared to the PP interpretation strategy. Although a substantial bronchodilator response is more likely to occur following abnormal baseline spirometry, 10–12% of subjects with normal baseline spirometry showed a substantial bronchodilator response. This suggests that normal baseline spirometry may miss reversible airway obstruction, which is a hallmark of asthma. Key words: spirometry; pulmonary function test; bronchodilator response; pediatric; FEV 1; FVC. [Respir Care 2013;58(5):785–789]
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Bronchodilation testing is an important component of spirometry testing, and omitting this procedure has potential clinical implications toward diagnosing respiratory diseases. We aimed to estimate the impact of bronchodilator testing in accurately diagnosing COPD and differentiating COPD from asthma-COPD overlap (ACO).The National Health and Nutrition Examination Survey data were analyzed from 2007-2012. Airflow limitation was defined by FEV1/FVC < 0.7. Subjects with pre-bronchodilator airflow limitation were classified into pre-but-not-post-bronchodilator airflow limitation and post-bronchodilator airflow limitation groups. Spirometry-confirmed COPD was defined by persistent airflow limitation on post-bronchodilator spirometry. The American Thoracic Society (ATS) and the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) definitions were used to identify possible ACO subjects.We identified 11,763 subjects ≥ 40 y of age eligible for spirometry; 625 of them had a pre-bronchodilator FEV1/FVC < 0.7 and completed post-bronchodilator spirometry that met ATS spirometry quality standards. A total of 244 (39%) of these subjects had only pre-not-post-bronchodilator airflow limitation, thereby not meeting the definition of spirometrically confirmed COPD. The prevalence of ACO was 7.6% using the modified ATS definition and 19.8% using the modified SEPAR criteria. When bronchodilator testing-based criteria were excluded from ATS and SEPAR definitions, the number of ACO subjects decreased by 39.3% and 12.3%, respectively.Spirometry with bronchodilation is an important element in the accurate diagnosis of ACO and COPD. Spirometry performed without bronchodilator testing may lead to an estimated misclassification of ACO by 7.6% to 19.8% and overdiagnosis of COPD by 39%.
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A modified double-blind study in 14 asthmatic patients had demonstrated that oral terbutaline (5 mg) resulted in significantly greater bronchodilation than did Tedral. Simultaneous ingestion of terbutaline and Tedral resulted in significantly greater bronchodilation than after either agent alone, which supports the concomitant use of beta-2 agonists and theophylline agents when treating patients with airflow obstruction.
Bronchodilation
Terbutaline
Bronchodilator Agents
Bronchodilatation
Concomitant
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Thirteen patients with severe partially reversible chronic obstructive lung disease received long-term treatment with a sustained-release preparation of theophylline and a beta 2-agonist (terbutaline) alone and in combination. Combination therapy induced significantly greater bronchodilation than treatment with terbutaline alone in the recommended dose. In 9 out of 13 patients the peak flows were higher during combination therapy than during theophylline treatment alone, but this did not reach statistical significance. Only mild side effects were observed.
Terbutaline
Bronchodilation
Combination therapy
Bronchodilator Agents
Obstructive lung disease
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The effect of six weeks9 treatment with inhaled terbutaline (1 mg four times a day), optimised doses of theophylline (twice a day), the combination of theophylline and terbutaline, and placebo was studied in a randomised, double blind, crossover trial. Thirty patients with partially reversible chronic airflow obstruction and a mean forced expiratory volume in one second (FEV1) of 1.2 litres that improved by 25% were included in the study. Patients who developed non-infective exacerbations of airflow obstruction that required additional bronchodilator treatment were classed as "treatment failures." Such treatment failure occurred in 23 patients with placebo, in 22 patients with theophylline, in 12 patients with terbutaline, and in two patients taking the two drugs. Mean daily peak flow readings were highest with the combination of the two drugs, followed by terbutaline and then theophylline, and lowest with placebo. Thus a combination of terbutaline and theophylline was superior to either drug alone; inhaled terbutaline was superior to theophylline alone. Theophylline alone does not appear to have much place in the management of patients with partially reversible obstructive airways disease.
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Crossover study
Bronchodilator Agents
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Abstract Background Chronic Obstructive Pulmonary Disease (COPD) is defined by post-bronchodilator spirometry. Data on “normal values” come predominantly from pre-bronchodilator spirometry. The effects of this on diagnosis are unknown. Methods Lower limits of normal (LLN) were estimated from “normal” participants in the Burden of Obstructive Lung Disease (BOLD) programme. Values separately derived using pre- and post-bronchodilator spirometry were compared. Sensitivity and specificity of criteria derived from pre-bronchodilator spirometry and pre-bronchodilator spirometry adjusted by a constant were assessed in the remaining population. The “gold standard” was the LLN for the post-bronchodilator spirometry in the “normal population”. For FEV1/FVC, sensitivity and specificity of criteria were also assessed when a fixed value of < 70% was used rather than LLN. Results Of 6,600 participants with full data, 1,354 were defined as “normal”. Mean differences between pre- and post- bronchodilator measurements were small and the Bland-Altman plots showed no association between difference and mean value. Compared with using the gold standard, however, tests using pre-bronchodilator spirometry had a sensitivity and specificity of detecting a low FEV1 of 78.4% and 100%, a low FVC of 99.8% and 99.1% and a low FEV1/FVC ratio of 65% and 100%. Adjusting this by a constant improved the sensitivity without substantially altering the specificity for FEV1 (99%, 99.8%), FVC (97.4%, 99.9%) and FEV1/FVC (98.7%, 99.5%). Conclusions Using pre-bronchodilator spirometry to derive norms for lung function reduces sensitivity compared to a post-bronchodilator gold standard. Adjustment of these values by a constant can improve validity of the test.
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Obstructive lung disease
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BACKGROUND:
Controversy exists regarding the best method to interpret pediatric spirometry. There is also controversy regarding the benefit of performing post-bronchodilator spirometry after normal baseline spirometry. This study compares the use of lower limit of normal (LLN) against percent of predicted (PP) in the interpretation of spirometry. We also investigate the occurrence of a substantial bronchodilator response for patients who received post-bronchodilator spirometry.METHODS:
Spirometric tests performed in the pediatric clinic at San Antonio Military Medical Center were retrospectively reviewed. Results of spirometry were compared using LLN and PP for interpretation. Abnormal spirometry was defined as a low FEV1 or low FEV1/FVC, indicating evidence of airway obstruction. The presence of a substantial bronchodilator response was recorded and the results were analyzed.RESULTS:
Of 242 tests, 212 normal and 30 abnormal tests were reported using the LLN interpretation strategy. Using the PP interpretation strategy, there was a significant difference in the number of normal (183) and abnormal (59) tests, when compared to the LLN (P < .001). No significant difference between LLN versus PP interpretation strategies was noted in the number of baseline tests, normal or abnormal, that demonstrated a substantial response to bronchodilator. Of the subjects with normal baseline spirometry, 10% (PP) and 12% (LLN) had a substantial bronchodilator response. An abnormal baseline spirometry was more likely to have a substantial response to bronchodilator, compared to normal baseline spirometry (P < .001).CONCLUSIONS:
The use of LLN for interpretation is more likely to report a test as normal, when compared to the PP interpretation strategy. Although a substantial bronchodilator response is more likely to occur following abnormal baseline spirometry, 10–12% of subjects with normal baseline spirometry showed a substantial bronchodilator response. This suggests that normal baseline spirometry may miss reversible airway obstruction, which is a hallmark of asthma.Airway obstruction
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