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Ipratropium (Ipratropium Bromide Monohydrate Inhalation) - Summary

 



IPRATROPIUM SUMMARY

Pharmacokinetics and Metabolism

The active ingredient in Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is ipratropium bromide monohydrate.

Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold for adults and children age 5 years and older. Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold.

The safety and effectiveness of the use of Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray) beyond four days in patients with the common cold has not been established.


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NEWS HIGHLIGHTS

Published Studies Related to Ipratropium (Ipratropium Cation Inhalation)

Treatment of clozapine-induced hypersalivation with ipratropium bromide: a randomized, double-blind, placebo-controlled crossover study. [2009.08]
CONCLUSIONS: Despite the reports of some preliminary studies that ipratropium is an efficacious treatment for CIH, ipratropium failed to demonstrate significant clinical effect in comparison to placebo. Further research should explore the efficacy of other locally acting anticholinergic agents or other classes of medications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00381589. 2009 Physicians Postgraduate Press, Inc.

Investigation of the effects of intranasal botulinum toxin type A and ipratropium bromide nasal spray on nasal hypersecretion in idiopathic rhinitis without eosinophilia. [2008.03]
Idiopathic rhinitis without eosinophilia is a group of frequently observed diseases, the aetiopathogenesis of which is not yet well known. One of the most disturbing symptoms for patients within this disease group is nasal hypersecretion.As a result, while IB and BTX-A differ in terms of method of application, they display a similar degree and duration of efficiency in hypersecretion therapy.

Modelling the 5-year cost effectiveness of tiotropium, salmeterol and ipratropium for the treatment of chronic obstructive pulmonary disease in Spain. [2007.06]
Our objective was to assess the 5-year cost effectiveness of bronchodilator therapy with tiotropium, salmeterol or ipratropium for chronic obstructive pulmonary disease (COPD) from the perspective of the Spanish National Health System (NHS). A probabilistic Markov model was designed wherein patients moved between moderate, severe or very severe COPD and had the risk of exacerbation and death...

Overcoming beta-agonist tolerance: high dose salbutamol and ipratropium bromide. Two randomised controlled trials. [2007.03.06]
BACKGROUND: Asthmatics treated with long-acting beta-agonists have a reduced bronchodilator response to moderate doses of inhaled short acting beta-agonists during acute bronchoconstriction. It is not known if the response to higher doses of nebulised beta-agonists or other bronchodilators is impaired. We assessed the effect of long-acting beta-agonist treatment on the response to 5 mg nebulised salbutamol and to ipratropium bromide... CONCLUSION: Long-acting beta-agonist treatment induces tolerance to the bronchodilator effect of beta-agonists, which is not overcome by higher dose nebulised salbutamol. However, the bronchodilator response to ipratropium bromide is unaffected.

Efficacy and tolerance of high-dose inhaled ipratropium bromide vs. terbutaline in intubated premature human neonates. [2007]
BACKGROUND: There is insufficient data to reliably assess the benefit of bronchodilators in ventilated premature neonates. OBJECTIVES: To compare the efficacy/tolerance of inhaled ipratropium bromide (IB) vs. terbutaline (T) and to describe factors associated with their efficacy... CONCLUSION: High doses of bronchodilators are required in ventilated neonates, but the positive response rate was <50%. Their long-term benefit remains to be proven. Copyright (c) 2007 S. Karger AG, Basel.

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Clinical Trials Related to Ipratropium (Ipratropium Cation Inhalation)

Effect of Ipratropium on Acute Bronchitis in Subjects Without Underlying Lung Disease [Completed]
ABSTRACT CONTEXT: Inappropriate antibiotic prescriptions for acute bronchitis is a major public health concern because of antibiotic resistance. Effective therapies for managing the symptoms of acute bronchitis are lacking, however.

OBJECTIVE: Determine if patients with acute bronchitis have better symptom control when treated with inhaled ipratropium.

DESIGN, SETTING, PARTICIPANTS: COUGH STOP was a randomized, double blind, placebo controlled trial comparing ipratropium with placebo in acute bronchitis. Subjects were referred by their primary care provider or from urgent care clinics at a single institution. Subjects had been diagnosed with acute bronchitis and had no significant co-morbidities.

INTERVENTION: Subjects received ipratropium or placebo inhalers, administering 2 puffs four times daily. A structured telephone interview took place 2, 4, and 8 days after enrollment. Medical records were reviewed at 60 days.

OUTCOME: The primary endpoint was improvement in cough symptomology; secondary endpoints included subsequent antibiotic prescriptions and “well being.” RESULTS: The ipratropium arm improved significantly (better: 57. 6% day-2, 68. 3% day-4, 91. 9% day-8; c2 (1) = 21. 24, p < .01) across the 8 days of the telephone survey. This score improved over the same time period in the placebo arm, however the change was smaller and the difference was not significant (better: 64. 8% day-2, 74. 6% day-4, 79. 7% day-8; c2 (1) = 4. 69, p =.321). More than twice as many subjects in the placebo arm received subsequent antibiotic prescriptions compared to the ipratropium arm (12 vs. 5 respectively), this trend did not meet the threshold of significance (c2 (1) = 2. 84, p =.076).

CONCLUSION: Patients with acute bronchitis who are otherwise healthy have a more rapid improvement in their cough symptom score when they are treated with ipratropium, and may be at decreased risk of unnecessary antibiotic exposure.

Acute Bronchodilator Response of a Single Dose of Atrovent or Berotec on Top of Pharmacodynamic Steady State of Spiriva [Completed]
To evalute acute effect of single dose of ipratropium (Atrovent) or fenoterol (Berotec) in comparison to placebo when given to COPD patients on pharmacodynamic steady state of tiotropium (Spiriva)

A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation [Recruiting]
This is a double blind, controlled clinical trail testing whether three doses of 1. 25 mg of nebulized levalbuterol in combination with three doses of 0. 5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1. 25 mg of levalbuterol alone every 20 minutes.

The primary hypothesis of this study is that three doses of 1. 25 mg of nebulized levalbuterol in combination with three doses of 0. 5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1. 25 mg of levalbuterol alone every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1, (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%, 30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.

Ipratropium Spray for Drooling Saliva in Parkinson's Disease [Completed]
A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease.

Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With COPD [Completed]
Comparison of 18 mcg of Tiotropium Inhalation Capsules and ipratropiumMetered Dose Inhaler (2 puffs of 20 mcg, four times daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (COPD).

The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 mcg once daily) and ipratropium MDI (2 puffs of 20 mcg q. i.d.) in patients with chronic obstructive pulmonary disease (COPD).

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Page last updated: 2009-10-20

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