Menu
×
News
Get Involved
About Us
Our Members
Table: Selected Clinical Trials on Sinupret®

Table: Selected Clinical Trials on Sinupret®

Acute Sinusitis

Author /Year

Subject

Design

Duration

Dosage

Preparation

Results

Neubauer & Marz, 1994

Acute sinusitis

R, PC, DB

n=160 men w/ acute bacterial sinusitis who were receiving antimicrobial (Vibramycin) & decongestant (Otriven) therapy (mean age 24.5 yrs)

2 wks

2 tablets 3x/d or placebo

Sinupret® Sugar Coated tablets

Patients in Sinupret group had greater improvement on their radiograms than those given placebo. Significantly more Sinupret-treated patients also showed improvement in mucosal swelling, nasal obstruction, & headache. According to patient assessment, significantly more Sinupret-treated patients found treatment favorable than those given placebo.

Biebach & Kramer, 2004

Acute sinusitis

OL, MC
n=3109 children w/ typical symptoms of sinusitis, including “much” and “viscous” nasopharyngeal discharge, impaired nasal breathing, & “moderately severe” cough. (n = 1638 girls and n = 1471 boys, mean age 6.9 years)

NR

64% of children received avg of 20 drops 3x/d. The number of drops was slightly reduced over course of study; specific details were NR. 10% of children (age 2-6 years) received 1 tablet 3x/d. 26% of children age 7-12 years received 1 tablet 3x/d. Concomitant medication was given to 74% of the children.

Sinupret drops & Sinupret Sugar Coated tablets

At final check-up, 93% of patients reported “little” nasal discharge or no discharge & 90% of cases reported discharge as “thin” & “clear.” Only 0.3% of the children reported severe impairment of nasal breathing & 75% had no cough. The effects of 2 dosage forms were similar in children aged 7-12 years. However, in children age 2-6 years, tablets were slightly superior to drops in treating stuffy nose & cough, while drops were more effective at improving facial pain & headache.

Kraus & Schwender, 1992

Acute sinusitis

R, OL, Cm
n=134 (gender NR but likely to be predominantly men since patients were at Germany Army Hospital, age NR)

3 wks

Sinupret dose NR or GeloMyrtol® forte dose NR

Sinupret Sugar Coated tablets, GeloMytrol 300 mg capsules

Percent of improvement was equivalent between treatments, w/ 49% of patients in both groups classified as having “nothing abnormal detected” or “improved.”

Braum & Marz, 1990

Acute sinusitis

R, OL, Cm
n=114 (gender NR but likely to be predominantly men since patients were at the Germany Army Hospital, age NR)

21 days

Sinupret: 2 tablets 3x/d or N-acetylcysteine: 200 mg 3x/d

Sinupret Sugar Coated tablets, N-acetylcysteine preparation NR

As determined by x-ray, 12.3% of Sinupret-treated patients improved & 56.1% were w/out pathologic findings, while 13.7% of N-acetylcysteine–treated patients improved & 43.1% were without pathologic findings. Approximately 85% of Sinupret-treated patients & 86.8% of N-acetylcysteine–treated patients reported that they were “improved” or “cured.”

Chronic Sinusitis

Richstein & Mann, 1999

Chronic sinusitis

R, DB, PC
n=31 (gender NR, age range: 6-73 years)

7 days

2 tablets 3x/d, or 50 drops 3x/day, or placebo

Sinupret Sugar Coated tablets, Sinupret drops

Radiologic & ultrasonographic findings of paranasal sinuses revealed that 12 of 16 Sinupret-treated patients had considerable improvement or complete recovery compared w/ 6 of 15 placebo-treated patients. Significantly more patients treated w/ Sinupret were headache-free after treatment. X-ray findings showed that paranasal sinuses were improved significantly more w/ Sinupret treatment. There was no difference between groups on posterior nasal secretion.

Braum & Marz, 1990

Exacerbation of chronic sinusitis

R, OL, Cm
n=46 (gender NR but likely to be predominantly men since the patients were at the Germany Army Hospital, age NR)

21 days

Sinupret: 2 tablets 3x/d or N-acetylcysteine: 200 mg 3x/d

Sinupret Sugar Coated tablets, N-acetylcysteine preparation NR

As determined by x-ray, 23.5% of Sinupret-treated patients improved & 41.7% were w/out pathologic findings, while 41.7% of N-acetylcysteine–treated patients improved & 20.8% were w/out pathologic findings (although it is not clear if assessment was made after 7 days or 21 days). Approximately 65% of Sinupret-treated patients & 61.9% of N-acetylcysteine–treated patients reported that they were “improved” or “cured.”

Acute Bronchitis

Pinnow & Egentenmaier, 1992

Uncomplicated acute bronchitis

Cm, B
n=158 (gender NR, age NR)

NR

Sinupret: dose NR or N-acetylcysteine: dose NR

Sinupret Sugar Coated tablets, N-acetylcysteine sustained release tablets

Efficacy of Sinupret was statistically equivalent to N-acetylcysteine. Sinupret had good or better effects on frequency of cough, sensation of pain, expectoration, & auscultation (breathing sounds).

Egentenmaier & Marz, 1991

Uncomplicated acute bronchitis

DB, Cm
n=80 (gender & age NR)

14 days

Sinupret: dose NR or ambroxol hydrochloride (Mucosolvan®): dose NR

Sinupret drops, ambroxol drops

Efficacy of Sinupret was significantly better than efficacy of ambroxol in well-matched patients. Sinupret was superior to ambroxol in daytime coughing frequency and sputum/amount.

Key: B: blinded, Cm: comparative, C: controlled, d: day, DB: double-blind, MC: multicenter, NR: not reported, OL: open-label, PC: placebo-controlled, PG: parallel group, R: randomized

Table: Selected Clinical Trials on Sinupret® Continued

Acute Sinusitis Continued