Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Engelhard Arzneimittel GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

14 Feb 2024 → 26 Apr 2024

Decision date (initial)

2024-02-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assessment of non-inferiority of Test vs. Reference 1 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment
Assessment of non-inferiority of Test vs. Reference 2 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment

Secondary objectives 7

1. Assessment of superiority of Test vs. Reference 1 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment
2. Assessment of superiority of Test vs. Reference 2 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment
3. Descriptive evaluation of differences in the change of BSS, between the Test product and each of the Reference products over the entire observation period between baseline and post-baseline visits
4. Descriptive evaluation of differences in cough severity (CS) determined using Visual Analogue Scale (VAS), between the Test product and each of the Reference products over the entire observation period between baseline and post-baseline visits
5. Descriptive evaluation of differences in CS determined using Verbal Category Descriptive (VCD) score, between the Test product and each of the Reference products over the entire observation period between baseline and post-baseline visits
6. Descriptive evaluation of global efficacy of all treatments assessed at post-baseline visits V6, V7 and V8 by patient and investigator
7. Descriptive evaluation of safety of all treatments over the entire observation period including Adverse Events and descriptive evaluation of global tolerability of all treatments assessed at post-baseline visits V6, V7 and V8 by patient and investigator

Conditions and MedDRA coding

Acute bronchitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Acute bronchitis with symptoms that have been present for 48-72 hours prior to treatment
2. Male or female patients of any ethnic origin
3. Age: 18 – 75 years, inclusive
4. Patients who are able to understand and are willing to follow the study rules
5. Patients who have given their written informed consent to participate in the study
6. With the exception of the existing bronchitis, good state of health as judged by the investigator based on medical history and physical examination
7. CS score of at least 50 mm on the 100 mm VAS at visit V1
8. BSS of at least 10 points at visit V1
9. VCD score of at least 2 points at visit V1

Exclusion criteria 17

1. Allergic bronchial asthma, bronchial hyperresponsiveness, chronic bronchitis, other chronic or hereditary lung diseases
2. History of hypersensitivity to any of the constituents of the IMPs
3. History of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis or current hay fever
4. History of chronic gastritis or peptic ulcer
5. Any gastrointestinal complaints within the last 7 days before visit V1
6. Patients with known hereditary fructose-intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency
7. Participation in a clinical trial within the last 30 days prior to the treatment phase of this study
8. Simultaneous participation in another clinical trial with active ingredients
9. Treatment with corticoids, beta-2 agonists (e.g., salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g., Aspirin with daily dose > 100mg) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, ACE inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate within the last 7 days before visit V1
10. Any other phytopharmaceutical medication (e.g. pelargonium extracts or other ivy preparations) or homeopathic medicines for the common cold within the last 7 days before visit V1
11. Patients who have been strictly forbidden by their doctor to take minimal amounts of alcohol (e.g., after a detoxification cure)
12. Medication, drug or alcohol abuse as judged by the investigator
13. Pregnant or lactating women
14. Body temperature >38.3°C
15. Women of childbearing potential who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol; Definition of women of childbearing potential and post-menopausal women is given in chapter 4.2.8 of the clinical trial protocol.)
16. Patients suffering from a significant condition, defined as a condition which, at the discretion of the investigator, either exposes the patient to a risk by participating in the study, or which affects the results of the study or the ability of the patient to participate in the study. This criterion includes patients with a history of gastrointestinal bleeding, significant cardiovascular, hepatic or renal disease.
17. Patients directly or indirectly involved in the conduct of this study, including employees of the sponsor, CRO and their relatives

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)

Secondary endpoints 6

1. Change of BSS between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V7, and V8 as well as baseline adjusted AUC
2. BSS at each post-baseline visits V2 to V8 and change of BSS between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V7, and V8, and related AUCs
3. CS assessed on VAS between visit V1 (baseline) and post-baseline visits (Area under the curve (AUC) generated with VAS values between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V6, V7, and V8 as well as baseline adjusted AUC)
4. CS assessed on VAS at each post-baseline visit and change of CS-VAS between visit V1 (baseline) and post-baseline visits, and related AUCs.
5. Change in CS assessed by VCD score between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V6, V7, and V8
6. Global efficacy (scores of a 5-point Likert scale by patient and investigator) at post-baseline visits V6, V7 and V8

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Engelhard Arzneimittel GmbH & Co. KG

Sponsor organisation

Engelhard Arzneimittel GmbH & Co. KG

Address

Herzbergstrasse 3

City

Niederdorfelden

Postcode

61138

Country

Germany

Scientific contact point

Organisation

Engelhard Arzneimittel GmbH & Co. KG

Contact name

Clinical Research Manager

Public contact point

Organisation

Engelhard Arzneimittel GmbH & Co. KG

Contact name

Clinical Research Manager

Third parties 1

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications