NEWS HIGHLIGHTS
Published Studies Related to Nasacort (Triamcinolone Nasal)
Triamcinolone-impregnated nasal dressing following endoscopic sinus surgery: a randomized, double-blind, placebo-controlled study. [2010.06]
OBJECTIVES/HYPOTHESIS: To evaluate the impact of steroid-impregnated absorbable nasal dressing on wound healing and surgical outcomes after endoscopic sinus surgery (ESS). STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial... CONCLUSIONS: Data analysis suggests a significant improvement in early postoperative healing in nasal cavities receiving triamcinolone-impregnated absorbable nasal packing following ESS and is also associated with improved healing up to 6 months postoperatively.
Comparison of azelastine versus triamcinolone nasal spray in allergic and nonallergic rhinitis. [2010.01]
BACKGROUND: Intranasal antihistamine has not been thoroughly studied in the treatment of rhinitis of different etiologies. This study was designed to show the comparative efficacy of nasal antihistamine and nasal corticosteroid in patients with allergic rhinitis (AR) and nonallergic rhinitis (NAR)... CONCLUSION: In this first comparative demonstration, AZENS appears to be as effective as triamcinolone in symptom scores, nPIFR, ESS, and HRQoL, equally in AR and NAR.
Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension. [2009.04]
BACKGROUND: Intranasal corticosteroids (INSs) are the most effective treatment for allergic rhinitis (AR). However, available INS safety and efficacy data in children younger than 6 years are limited. OBJECTIVE: To report the first well-controlled study assessing the safety and efficacy of an INS in children aged 2 to 5 years with perennial AR... CONCLUSIONS: Use of TAA AQ, 110 microg once daily, for up to 6 months offers a favorable efficacy to safety ratio in children aged 2 to 5 years with perennial AR.
Comparison of intranasal hypertonic dead sea saline spray and intranasal aqueous triamcinolone spray in seasonal allergic rhinitis. [2005.07]
Intranasal corticosteroids are well known to be efficacious in the treatment of allergic rhinitis. Nasal irrigation with saline, including hypertonic saline, has long been recommended for the treatment of sinonasal disease, and it has been shown to have a positive effect on the physiology of the nasal mucosa...
Determination of triamcinolone in human plasma by a sensitive HPLC-ESI-MS/MS method: application for a pharmacokinetic study using nasal spray formulation. [2011.03]
A liquid chromatography-electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method for the quantitation of triamcinolone in human plasma after nasal spray application was developed and validated. Betamethasone was used as internal standard (IS)... The validated method was successfully applied to determine the plasma concentrations of triamcinolone acetonide in healthy volunteers, in a pharmacokinetic study with nasal spray formulation.
Clinical Trials Related to Nasacort (Triamcinolone Nasal)
A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema involving the center of the macula who have not already been given maximal laser
treatment.
Patients with one study eye will be randomly assigned (stratified by prior laser) with equal
probability to one of five treatment groups:
1. Focal laser photocoagulation (modified ETDRS technique)
2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
3. Anterior peribulbar injection of 20 mg triamcinolone
4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser
5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of
the five treatment groups listed above. If the right eye was assigned to laser only, then the
left eye will be assigned to one of the four triamcinolone groups above with equal
probability (stratified by prior laser). If the right eye was assigned to receive
triamcinolone, then the left eye will receive laser only.
Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone
acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb
and is approved by the Food and Drug Administration for intramuscular use for a variety of
indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular
conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many
years.
Two different triamcinolone regimens will be assessed in the study: 40 mg injected
posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen
will be better. Although the injection behind the eye is more common than the injection near
the front of the eye, the injection near the front of the eye has less risk of injuring the
eye. However, it is possible that the injection near the front of the eye may increase eye
pressure more frequently. Little is known about which of the two injections decreases macular
edema and improves vision more often.
Patients enrolled into the study will be followed for three years and will have study visits
1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study
treatment. For the first 8 months of the study, patients should only be retreated with their
randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or
more, then any treatment may be given at the investigator's discretion. After completion of
the 8-month visit, treatment is at investigator discretion.
The primary objective of this study is to obtain estimates of efficacy and safety outcomes
for each of the treatment groups. These estimates will provide a basis for the sample size
estimation and hypothesis generation in a phase III trial.
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema [Active, not recruiting]
The study involves the enrollment of patients over 18 years of age with diabetic macular
edema. Patients with one study eye will be randomly assigned (stratified by visual acuity and
prior laser) with equal probability to one of the three treatment groups:
1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection
For patients with two study eyes (both eyes eligible at the time of randomization), the right
eye (stratified by visual acuity and prior laser) will be randomly assigned with equal
probabilities to one of the three treatment groups listed above. The left eye will be
assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned
to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with
equal probability (stratified by visual acuity and prior laser).
The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal
injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will
receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will
be better.
Patients enrolled into the study will be followed for three years and will have study visits
every 4 months after receiving their assigned study treatment. In addition, standard of care
post-treatment visits will be performed at 4 weeks after each intravitreal injection.
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata [Recruiting]
The purpose of the study is to see whether treating alopecia areata with injections of the
corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal
glands.
Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery? [Recruiting]
The investigators hypothesize that intracameral Triesence during glaucoma surgery will
provide lower intraocular pressure through better control of ocular inflammation, thus
leading to a more successful filtering procedure.
Intraocular Bevacizumab Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema [Recruiting]
The purpose of this study is to investigate the change in macular edema and the absolute
change in visual acuity following intravitreal administered injections of Bevacizumab
(AvastinŽ) compared with Triamcinolone (Volon AŽ) in patients with clinical significant
diabetic macular edema.
The investigators monitor the change in macular edema measured with standard optical
coherence tomography (OCT) and the absolute change in visual acuity analyzed by standardized
charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study
(ETDRS).
|
