Comparison of the Bronchodilatation of Ipratropium Bromide and Fenoterol Nebuliser Solutions Administered Alone and in Combination
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Bronchodilatation
Ipratropium bromide
Fenoterol
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Bronchodilatation
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Ipratropium bromide
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Summary: The bronchodilator effects of 40 μg ipratropium bromide (I) and 400 μg fenoterol (F) by pressurised aerosol and both drugs in combination were compared with placebo (P) in a double‐blind study in eight patients with chronic, partially reversible airways obstruction. The four treatments were (1) IP, (2) PF, (3) IF and (4) PP, with the second aerosol administered two hours after the first. Both drugs produced significant bronchodilatation for five hours, the response being greater and more rapid in onset with fenoterol. Both drugs in combination (IF) produced significant additive bronchodilatation from three to six hours after fenoterol. This additive effect may have been due to the improved lung function caused by ipratropium bromide and does not imply a synergistic effect. There were no side‐effects reported. The results suggest that both ipratropium bromide and fenoterol are effective bronchodilating agents in patients with chronic asthma.
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Two double-blind, placebo-controlled studies were performed in patients with chronic, partially reversible airflow limitation to compare ipratropium bromide and fenoterol administered singly with the combination treatment. In the first study, ipratropium bromide, 40 µg, or placebo was administered 2 h before fenoterol, 400 µg, or placebo, both by metered-dose inhaler. The combined treatment demonstrated significant additive bronchodilatation with an improved forced expiratory volume in 1 s (FEV1) response from 3 to 6 h after fenoterol administration. In the second study, ipratropium bromide, 0.5 mg, fenoterol, 2.0 mg, or placebo was administered by aerosolized solution with a nebulizer. The FEV1 response to the combined treatment, administered at the same time, was significantly greater than for fenoterol (0.5, 0.75, 4 and 6 h) and for ipratropium bromide (0.25–1.5, and 4 h) at various times. There was a disproportionate increase in forced vital capacity (FVC) compared with FEV1 for all treatments, suggesting dilatation and increased stability of small airways. In both studies, no synergistic effect is implied. In summary, additive bronchodilatation may be achieved with combined ipratropium bromide and fenoterol treatment by metered-dose inhaler or aerosolized solution.
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A double-blind, randomized trial was carried out in 48 children to assess the effects of inhaled ipratropium bromide, fenoterol or a combination of both drugs in treating their moderately severe acute asthma. Doses were adjusted according to the age of the patients and administered by nebulizer. Measurements of pulse rate and respiratory rate and assessment of the severity of symptoms were made at fixed intervals during the first 2 hours on treatment. Repeat nebulizations were given, if necessary, at 2-hourly intervals. The results suggested that fenoterol provided the most adequate treatment and there was no evidence to indicate that the addition of ipratropium produced any improved benefit.
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We performed a dose-response study of ipratropium bromide as a nebulized solution in patients with stable chronic obstructive pulmonary disease (COPD) using a double-blind crossover format. Five doses from 0.05 to 0.6 mg of ipratropium bromide as a nebulized solution, the standard dose of ipratropium bromide by metered-dose inhaler, 40 µg, and placebo were given in random order on separate days. End points were the maximal increase in FEV1 and FVC, and the area under the FEV1 and FVC curves in the 8 h after administration of each of the seven treatments.Forty-two patients completed all seven study days. By each of the above end points for FEV1, 0.4 and 0.6 mg of nebulized ipratropium bromide achieved significantly more bronchodilatation than did each of the other treatments. These two doses were not significantly different from each other, suggesting that the optimal dose in this patient population is 0.4 mg. After this dosage, the FEV1 increased by 440 ± 194 (mean ± 1 SD) ml at peak effect between 1 and 2 h, and significant bronchodilatation persisted for 6.5 h. Ipratropium bromide by metered-dose inhaler (40 µg) was equivalent to approximately 0.1 mg by nebulized solution and achieved only 63 to 73% of the bronchodilatation achieved by optimal doses of the nebulized solution. In terms of FVC, all treatments with ipratropium were significantly better than with placebo. The area under the FVC curve was significantly greater after 0.4 and 0.6 mg of nebulized solution than after other treatments. No significant adverse experiences occurred with any of the treatments. In stable COPD the optimal dose of ipratropium bromide as a nebulized solution is 0.4 mg.
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Crossover study
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The efficacies of inhaled doses of fenoterol 200 micrograms, ipratropium bromide 40 micrograms and their combination (200 + 40 micrograms) were compared in a double-blind, placebo-controlled cross-over study in 24 adult patients with stable asthma bronchiale. The tests were performed during 4 consecutive days. The change in bronchial obstruction was assessed by means of spirometry [forced expiratory volume in 1 s (FEV 1.0), forced vital capacity (FVC), peak expiratory flow (PEF)] and body plethysmography [thoracic gas volume (TGV), airway resistance (Raw)] measurements. The values of FEV% and specific airway conductance (SGaw) were calculated. The frequency of side-effects was recorded. During the treatment with the combination of ipratropium bromide and fenoterol the change in the mean SGaw differed highly significantly (p less than 0.001) from placebo in the initial bronchodilator response and at 3, 4 and 5 h. With fenoterol, compared to placebo, a highly significant difference in bronchodilator effect lasted for 4 h, with ipratropium bromide for 3 h. Similarly, a highly significant difference measured with FEV 1.0 during the medication with the combination of ipratropium bromide and fenoterol lasted for 4 h, with fenoterol alone for 2 h, and with ipratropium alone for 1 h. The most harmful side-effect in this group of asthmatics proved to be muscular tremor, caused most often by the combination of ipratropium bromide and fenoterol. The findings of this study suggest that the combination of ipratropium bromide and fenoterol gives a stronger bronchodilatation and a more prolonged effect in asthmatics than ipratropium bromide or fenoterol alone.(ABSTRACT TRUNCATED AT 250 WORDS)
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Fenoterol
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Ipratropium bromide
Ipratropium
Bronchodilatation
Parasympatholytics
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Ipratropium bromide (0.5 mg) and fenoterol (2 mg) produced equivalent peak bronchodilatation between 1 and 2 h after administration to eight patients with chronic partially reversible airways obstruction. The duration of action compared with saline was 6 h for ipratropium and 4 h for fenoterol. Both drugs in combination produced greater bronchodilatation than either drug alone. The increase in FVC was disproportionately greater than FEV1 with both drugs and saline, suggesting relief of obstruction of small airways.
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The efficacy and safety of a novel fenoterol/ipratropium bromide metered-dose inhaler (MDI) formulated with a non-chlorinated propellant, HFA134a, has been compared with placebo and the conventional chlorofluorocarbon (CFC)-containing fenoterol/ipratropium bromide inhaler (Berodual) in asthmatic patients. Fifty-two patients were enrolled in two centres. The fenoterol/ ipratropium bromide treatment produced significantly (P < 0.0001) greater bronchodilatation than placebo. There were no significant differences between the mean peak and average forced expiratory volume in the first second (FEV1) for patients receiving 2 puffs of the fenoterol/ipratropium bromide HFA134a inhaler and the conventional CFC inhaler. In addition, time to onset and duration of efficacy were comparable for these two treatments. None of the patients showed a fall of > or = 15% in baseline FEV1 or needed rescue medication within 30 min after inhalation of the test drug. No paradoxical bronchoconstriction was observed as measured by sGaw. The two inhaler formulations were well tolerated. A taste-related complaint, lasting for a few minutes after inhalation, was reported by a higher proportion of patients who inhaled the HFA134a formulation, mainly by patients selected in one of the two centres. In conclusion, a dose of 100 micrograms fenoterol/40 micrograms ipratropium bromide inhaled from a MDI containing HFA134a propellant is safe and provides effective bronchodilatation of equivalent degree, onset and duration of action to the same dose from the conventional CFC formulation.
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