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Intal (Cromolyn Sodium Inhalation) - Summary



Intal® Inhaler
(cromolyn sodium inhalation aerosol)

The active ingredient of Intal Inhaler is cromolyn sodium, USP. It is an inhaled anti-inflammatory agent for the preventive management of asthma. Cromolyn sodium is disodium 5,5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4 H -1-benzopyran-2-carboxylate].

Intal Inhaler is a prophylactic agent indicated in the management of patients with bronchial asthma.

In patients whose symptoms are sufficiently frequent to require a continuous program of medication, Intal Inhaler is given by inhalation on a regular daily basis. (See DOSAGE AND ADMINISTRATION.) The effect of Intal Inhaler is usually evident after several weeks of treatment, although some patients show an almost immediate response.

If improvement occurs, it will ordinarily occur within the first 4 weeks of administration as manifested by a decrease in the severity of clinical symptoms of asthma, or in the need for concomitant therapy, or both.

In patients who develop acute bronchoconstriction in response to exposure to exercise, toluene diisocyanate, environmental pollutants, known antigens, etc., Intal Inhaler should be used shortly before exposure to the precipitating factor, i.e., within 10 to 15 minutes but not more than 60 minutes. (See DOSAGE AND ADMINISTRATION.) Intal Inhaler may be effective in relieving bronchospasm in some, but not all, patients with exercise induced bronchospasm.

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Published Studies Related to Intal (Cromolyn Inhalation)

Efficacy of topical cromolyn sodium 4% on pruritus in uremic nephrogenic patients: a randomized double-blind study in 60 patients. [2012]
pruritus... CONCLUSION: According to our study cromolyn sodium cream 4% was more effective

Effect of oral cromolyn sodium on CKD-associated pruritus and serum tryptase level: a double-blind placebo-controlled study. [2010.05]
BACKGROUND: Generalized pruritus is a significant complication in end-stage renal disease patients. The mechanism is unknown and most treatments are ineffective. This study is the first clinical trial designed to evaluate the effect of cromolyn sodium (CS) on renal itch... CONCLUSION: CS can significantly reduce the severity of pruritus in HD patients, but this effect is not due to a decrease in serum tryptase level.

Effect of oral cromolyn sodium on CKD-associated pruritus and serum tryptase level: a double-blind placebo-controlled study. [2010]
cromolyn sodium (CS) on renal itch... CONCLUSION: CS can significantly reduce the severity of pruritus in HD patients,

Gamma scintigraphy for testing bioequivalence: a case study on two cromolyn sodium nasal spray preparations. [2008.06.05]
The present work was carried out to study the deposition patterns and clearance of technetium-99m (99mTc) DTPA labeled cromolyn sodium (CS) solutions when administered from two different CS nasal products using gamma scintigraphy. Five healthy volunteers received a single dose with complete crossover design involving treatment A (test formulation) and treatment B (reference formulation).

Promising ternary dry powder inhaler formulations of cromolyn sodium: formulation and in vitro-in vivo evaluation. [2007.06]
Glucose monohydrate and sorbitol were evaluated as alternative carriers to a-lactose monohydrate in dry powder inhalations. Cromolyn sodium (CS) - carrier binary formulae were prepared and tested in vitro by aerosolization via a twin stage impinger using three types of inhaler devices; Spinhaler, Aerolizer and Handihaler...

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Clinical Trials Related to Intal (Cromolyn Inhalation)

Cromoglicate in Psoriasis [Recruiting]

Cromoglicate in Mastocytosis [Recruiting]
The purpose of this exploratory study is to investigate the clinical efficacy of study drug (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded, randomised, single centre setting.

Treatment of Acute Stroke With Cromolyn(Single Dose) [Not yet recruiting]
Mastocytes were proven to have a central rule in their development of the lipoid plaque of the vascular system. Mastocytes also has an important role in the stabilisation of the plaque in the building of the brain barrier. Different animal studies show that the inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic stroke. It was also shown that post stroke inflammation process was also blocked by the inhibition of mastocytes. Other studies showed up to 100% decrease in the brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.

Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used in the previously mentioned studies.

Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus [Recruiting]
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli. Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells. Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.

To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol [Recruiting]
This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e. g. forced expiratory volume in one second (FEV1)) will be measured in order to assess the protective effect of the study medication.

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Page last updated: 2013-02-10

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