Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma

NCT01478152 | Completed

• 1 other identifier: K-AN
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma. This dose-finding study will estimate the minimum effective dose and will assess the safe dosage, in terms of the quantity given to patients. The results will be compared to baseline measurements. The results regarding Sputum measurements will be compared to measurements after placebo administration.

Conditions

Asthma

Keywords

Asthma; Ectoin; Ectoine; FeNO; Metacholin; sRaw

Outcome Measures

Primary Outcomes (1)

• Dose of Metacholine needed to produce a 20% drop in FEV1 as reflection of airway hyperreagibility

  Methacholine cumulative dose producing a 20% decrease in Forced Expiratory Volume in 1 second (FEV1) (defined as PD20)

  5 to 7 days

Study Arms (1)

Ectoin Inhalation Solution

EXPERIMENTAL

After baseline visit subjects will receive 0.9% saline inhalation solution for placebo. Patients will be instructed to inhale once daily with the AKITA2® APIXNEB® inhalation system for 5 - 7 days. The treatment phase with low dose of Ectoin® will follow subsequently without any washout phase. This treatment phase will be repeated for medium and a high Ectoin® dose. All doses of Ectoin® inhalation solution will be administered for 5 - 7 days without any washout phase. Sputum inductions will be conducted on the last but one day of placebo treatment phase and on the last but one day of treatment phase with the highest Ectoin® dose.

Other: Drug-like Medical Device: Ectoin Inhalation Solution

Interventions

Drug-like Medical Device: Ectoin Inhalation Solution OTHER

After baseline visit subjects will receive 0.9% saline inhalation solution for placebo. Patients will be instructed to inhale once daily with the AKITA2® APIXNEB® inhalation system for 5 - 7 days. The treatment phase with low dose of Ectoin® will follow subsequently without any washout phase. This treatment phase will be repeated for medium and a high Ectoin® dose. All doses of Ectoin® inhalation solution will be administered for 5 - 7 days without any washout phase. To minimize circadian variations Methacholine challenge tests will be performed always at the approximately same time. Sputum inductions will be conducted on the last but one day of placebo treatment phase and on the last but one day of treatment phase with the highest Ectoin® dose.

Ectoin Inhalation Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 - 65 years)
• FEV1 ≥ 80% of predicted for patient's normal value pre bronchodilator (according to European Coal and Steel Community reference values)
• Positive Methacholine challenge test (PD20 ≤ 0.5 mg)
• A general practitioner or consultant diagnosed mild bronchial asthma
• Non or ex smoker (for more than 6 months, pack years (PY) ≤ 5)

You may not qualify if:

• Pregnant or lactating females
• Participation in another clinical study in the previous month
• Severe concomitant disease which may have an impact on the study participation
• Hypersensibility against Ectoin®
• Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit).
• Other respiratory diseases (e.g. Chronic obstructive pulmonary disease (COPD), cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, bronchiectasis, allergic alveolitis, tuberculosis, etc.)
• Upper and lower airway respiratory infection within 4 weeks prior to study start

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

Inamed Research GmbH & Co KG

Gauting, Bavaria, 82131, Germany

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Meyer, MD

  Inamed Research GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 23, 2011
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (1)