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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)

The effect of administrative cessation of the use of ipratropium bromide in the treatment of acute asthma attacks in the emergency department. [2011.12]
Background.

Inhaled salbutamol plus ipratropium in moderate and severe asthma crises in children. [2011.04]
BACKGROUND: The combination of inhaled beta(2) agonists and anticholinergics is recommended for children with acute asthma, although there are few randomized controlled trials. The aim of the study was to determine whether salbutamol plus ipratropium bromide improves oxygenation and lung function and reduces the frequency of hospitalization in children with asthma crises... CONCLUSIONS: Salbutamol plus ipratropium bromide improves lung function in asthmatic children with moderate to severe asthma crises, independently of age. The effect is greater in children with severe crises, with a substantial reduction in the need for hospitalization.

Levalbuterol versuss levalbuterol plus ipratropium in the treatment of severe acute asthma. [2010.12]
BACKGROUND: The National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 guidelines advise the addition of ipratropium bromide to short-acting beta-agonist therapy for the treatment of patients with severe acute asthma exacerbation... CONCLUSION: We were unable to demonstrate superiority of adding ipratropium to levalbuterol in alleviating obstruction as measured by FEV or in decreasing the need for hospitalization among adult patients presenting to the ED with acute severe asthma exacerbation.

Functional response to inhaled salbutamol and/or ipratropium bromide in Ascaris suum-sensitised cats with allergen-induced bronchospasms. [2010.10]
Knowledge about the use of inhaled bronchodilators in cats with so-called 'feline asthma' is limited and relies on the experience of clinicians treating these patients. A randomised controlled four-way crossover study was therefore designed to compare the effects of salbutamol (SAL, 100 mug), ipratropium bromide (IB, 20 mug) and a combination of both (SAL/IB, 100 mug/20 mug), delivered through a pressurised metered-dose inhaler (pMDI) connected to a spacing chamber, on allergen-induced bronchospasms in five Ascaris suum (AS)-sensitised cats...

Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. [2010.08]
We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study...

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Clinical Trials Related to Ipratropium (Ipratropium Cation Inhalation)

Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes [Recruiting]
Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The mechanisms of asthma appear to be different between athletes and non-athletes, in that the occurrence of asthma is higher among endurance athletes and seems to be promoted by training. This suggests that factors inherent to athleticism, such as the parasympathetic nervous system, which has been shown to change with endurance training and is known to lead to narrowing of the airways, may be involved with the development of asthma in athletes. Although asthma mechanisms and treatments have been extensively studied in classic asthmatics, there is very limited data in athletes. This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug. We will also obtain a blood sample from all athletes to test for allergies and evaluate whether our results are affected by atopic predisposition. If ipratropium bromide proves to prevent EIA in athletes, this drug may be more appropriate and effective than the currently used beta-2 agonists to target EIA in this population. The results of this study may lead to improved clinical management of athletes with asthma.

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.

A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium [Recruiting]
The objective of this study is to assess the daily variation in bronchodilator response to an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting anticholinergic (ipratropium) individually and when used in combination in subjects with COPD.

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)

An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs. [Recruiting]
GSK961081 is a potent dual pharmacophore that demonstrates both antimuscarinic and beta-agonist pharmacology in preclinical studies, both pharmacologies being of long duration. If reproduced in man, GSK961081 has the potential to deliver a medicine that can be given once daily. The bronchodilatation after inhalation of single doses of GSK961081 alone and in the presence of the short acting beta agonist salbutamol and the short acting muscarinic antagonist, ipratropium bromide will be measured in this study. Any residual bronchodilatation post-inhalation of GSK961081 and demonstrated by addition of salbutamol or ipratropium bromide may provide an indirect assessment of the beta-agonist and antimuscarinic components of GSK961081.

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Page last updated: 2011-12-09

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