Acute PharyngitisNCT02160912
Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
An observational study of Acute Pharyngitis and Acute Laryngitis, run by Bitop AG at 8 sites in Germany.
Trial summary
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Acute Pharyngitis, Acute Laryngitis
- How many people
- 95 participants
- Where
- 8 sitesGermany
- Study dates
- Feb 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care unit In this non interventional study the therapy process of a total of 90 patients with acute pharyngitis and/or laryngitis for which the physician has planned a therapy with Ectoin Mund- \& Rachenspray 1% (60 Patients) or Emser Pastillen (30 patients) shall be observed in 8 clinical centers
Who may be able to join
- Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen
Who cannot join
- contraindications according to instructions for use
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Norbert Pasch-Facharzt für HNO Heilkunde
Aachen, 52074
HNO Praxis Aachen Brand
Aachen, 52078
Taufik Shahab -Facharzt für HNO Heilkunde
Cologne, 50667
Bey - Facharzt f. HNO Heilkunde
Cologne, 50933
HNO-Praxis Peter Hinterkausen & Dr. med. Eva Bottler-Neufert
Cologne, 50935
HNo Praxis Dr. Uta Thieme
Duisburg, 47051
Dr. Lenzenhuber-Fachärztin für HNO Heilkunde
Jülich, 52428
Wilhelm Schütz -Facharzt für HNO Heilkunde
Jülich, 52428
About this study
Official title: Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.
Patients are treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.
- Conditions
- Acute Pharyngitis, Acute Laryngitis
- Medical subject headings
- Croup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Mund- & Rachenspray | treatment with Ectoin Mund- \& Rachenspray 1% | |
| Emser Pastillen | treatment with Emser Pastillen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pharyngitis symptom score evaluated by the physician
Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong):
- swollen palatine tonsils
- swollen lymph nodes in the throat
- fever
- cough
Measured: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)
Secondary outcomes (8)
Change in patient's general condition evaluated by the physician
Physician's assessment of the general conditions on a 4 point scale (good condition, slightly reduced condition, bad condition, very bad condition)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Evaluation of the hoarseness
physician's assessment of the hoarseness of the patient on a 4 point scale (none, mild, moderate, strong)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Dysphagia
physician's assessment of dysphagia of the patient on a 4 point scale (none, mild, moderate, strong)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in efficacy evaluation by the physician
Assessment of the efficacy on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)
Change in efficacy evaluation by the patient
Assessment of the efficacy on a 4 point scale (0_bad, 1=sufficient, 2=good, 3=very good)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Evaluation of the tolerability by the physician
Assessment of the tolerability by the physician on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in Evaluation of the tolerability by the patient
Assessment of the tolerability by the patient on a 4 point scale (0= bad, 1=sufficient, 2=good, 3=very good)
Measured: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in number and type of adverse events
incidence of adverse events and correlation with the therapy
Measured: Visit 2 (after 3 days) Visit 3 (after 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Mösges, MD, Principal investigator, Klinikum der Universität zu Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160912
- Sponsor's protocol ID
- EctMRS/aLR/2014
- Status last verified
- Jan 2015
- First submitted
- 4 Jun 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT02160912
- Acronym / sponsor ID
- EctMRS/aLR/2014
- Conditions
- Acute Pharyngitis, Acute Laryngitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this observational study insights regarding the tolerability and influence on the quality of life of the topical treatment Ectoin Mund- and Rachenspray compared to Emser Pastillen in patients with acute Pharyngitis/ Laryngitis under real life conditions shall be gained.
Patients are treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen according to the demands of the physician and the instructions for use.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin Mund- & Rachenspray | – | –treatment with Ectoin Mund- \& Rachenspray 1% |
| Emser Pastillen | – | –treatment with Emser Pastillen |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care unit In this non interventional study the therapy process of a total of 90 patients with acute pharyngitis and/or laryngitis for which the physician has planned a therapy with Ectoin Mund- \& Rachenspray 1% (60 Patients) or Emser Pastillen (30 patients) shall be observed in 8 clinical centers
Key inclusion criteria (1 listed)
- Patients with acute Laryngitis and/or Pharyngitis which are already treated with Ectoin Mund- \& Rachenspray 1% or Emser Pastillen
Key exclusion criteria (1 listed)
- contraindications according to instructions for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pharyngitis symptom score evaluated by the physician
Time frame: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)
Assessment of the symptoms of pharyngitis on a 4 point scale (none, mild, moderate strong): * swollen palatine tonsils * swollen lymph nodes in the throat * fever * cough
8 secondary outcomes
Change in patient's general condition evaluated by the physician
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Evaluation of the hoarseness
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Dysphagia
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in efficacy evaluation by the physician
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 1 week)
Change in efficacy evaluation by the patient
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days)
Change in Evaluation of the tolerability by the physician
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in Evaluation of the tolerability by the patient
Time frame: Visit 1, Visit 2 (after 3 days), Visit 3 (after 7 days))
Change in number and type of adverse events
Time frame: Visit 2 (after 3 days) Visit 3 (after 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
Related trials for Acute Pharyngitis
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
RecruitingObservational study
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
Acute Rhinitis, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Mösges, MD principal investigator
Klinikum der Universität zu Köln
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pharyngitis and Acute Laryngitis, run by Bitop AG at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pharyngitis symptom score evaluated by the physician (time frame: Visit 1, Visit 2 (after 3 days), Visite 3 (after 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.