BronchitisNCT02632851
Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
An observational study of Bronchitis and Cough, run by Bitop AG at 1 site in Germany.
Trial summary
This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Bronchitis, Cough, Sputum, Cellular Atypia
- How many people
- 135 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Jun 2016
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care or ENT units study the therapeutic process in this obvservational trial in total of 120 patients suffering on respiratory tract infection and/or acute bronchitis
Who may be able to join
- according to instruction for use
Who cannot join
- according to instruction for use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution
Read the detailed description
The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea
- Conditions
- Bronchitis, Cough, Sputum, Cellular Atypia, Dyspnoea
- Keywords
- inhalation, isotonic saline, NaCl solution 0.9 %, Ectoin, bronchitis, respiratory tract infection
- Medical subject headings
- Bronchitis, Cough, Dyspnea, Respiratory Aspiration, Respiratory Tract Infections
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 inhalation solution | treatment according to instructions for use | |
| Pari NaCl inhalation solution (0.9%) | treatment according to instructions for use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
Assessment of bronchits severity score on a 5 point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration) of symptoms:
Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
Measured: day 7
Secondary outcomes (6)
Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)
Assessment of bronchits symptoms on a 5 point scale (absent, mild, moderate, severe, very severe) of symptoms:
Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
Measured: day 14
patients´ evaluation of tolerability (4 point scale)
assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
Measured: day7
physicians´ evaluation of tolerability (4 point scale)
assessment of tolerability on a 4 point scale (bad, satisfied, good, very good)
Measured: day 7
patients´ evaluation of efficacy (five point IMOS scale)
assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
Measured: day 7
physicians´ evaluation of efficacy (five point IMOS scale)
assessment of tolerability on a five point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration)
Measured: day 7
Change in number and type of adverse events
incidence of adverse events and correlation with the therapy
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchitisStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Mösges, Prof Dr, Study chair, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632851
- Sponsor's protocol ID
- EIL/aBr/2015
- Status last verified
- Jun 2016
- First submitted
- 2 Dec 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Curr Med Res Opin. 2013 Oct;29(10):1383-90. doi: 10.1185/03007995.2013.832183. Epub 2013 Aug 23.
PubMed 23927521
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Multicentric Study on Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution
- ClinicalTrials.gov ID
- NCT02632851
- Acronym / sponsor ID
- EIL/aBr/2015
- Conditions
- Bronchitis, Cough, Sputum, Cellular Atypia, Dyspnoea
- Keywords
- inhalation, isotonic saline, NaCl solution 0.9 %, Ectoin, bronchitis, respiratory tract infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Dec 2015 (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.
This observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution
Detailed description
The assessment focuses on the bronchitis Severity Score (BSS) for standardized use in clinical studies with the outcome criteria of cough, sputum production, rales/rhonchi, chest pain during coughing and dysnoea
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ectoin inhalation solution | – | –treatment according to instructions for use |
| Pari NaCl inhalation solution (0.9%) | – | –treatment according to instructions for use |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care or ENT units study the therapeutic process in this obvservational trial in total of 120 patients suffering on respiratory tract infection and/or acute bronchitis
Key inclusion criteria (1 listed)
- according to instruction for use
Key exclusion criteria (1 listed)
- according to instruction 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 Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale)
Time frame: day 7
Assessment of bronchits severity score on a 5 point IMOS scale (complete recovery, major improvement, slight to moderate improvement, no change, deterioration) of symptoms: Cough, sputum production, rales/rhonchi, chest pain during coughing, dyspnoea
6 secondary outcomes
Change in bronchitis symptoms evaluated on patients´ diaries (5 point scale)
Time frame: day 14
patients´ evaluation of tolerability (4 point scale)
Time frame: day7
physicians´ evaluation of tolerability (4 point scale)
Time frame: day 7
patients´ evaluation of efficacy (five point IMOS scale)
Time frame: day 7
physicians´ evaluation of efficacy (five point IMOS scale)
Time frame: day 7
Change in number and type of adverse events
Time frame: day 7
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 21 Jun 2016.
- Background: PubMed 23927521Matthys H, Kamin W. Positioning of the Bronchitis Severity Score (BSS) for standardised use in clinical studies. Curr Med Res Opin. 2013 Oct;29(10):1383-90. doi: 10.1185/03007995.2013.832183. Epub 2013 Aug 23.
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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.
R Mösges, Prof Dr study chair
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchitis and Cough, run by Bitop AG at 1 site 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Bronchitis Severity Score on physician´s evaluation (5 point IMOS scale) (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632851, which also lists 1 linked publication.
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 21 Jun 2016.