A single dose study to compare the effect of bronchodilatation of two formulations of SMB tiotropium products versus the marketed product Spiriva® 18 µg Handihaler®

Phase 1

• Conditions: Chronic obstructive pulmonary disease (bronchodilating effect); MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-004095-19-BG
• Lead Sponsor: aboratoires SMB S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-19
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

nclusion criteria

Patients must satisfy the following criteria before entering the study:
1.Male and non-pregnant female aged over 40 years old
2.Documented history of stable COPD with moderate to severe airflow obstruction diagnosed for more than six months according to the GOLD standard prior to the screening visit
3.FEV1 more than or equal to 30% and inferior to 80% of predicted at screening.
4.FEV1/FVC following 200 µg salbutamol treatment intake < 0.7 at screening.
5.Reversibility of at least 12% and 100 ml in FEV1 30-45 minutes after maximum 400 µg of salbutamol
6.Current smokers or history of ex-smokers (=10 pack-year smoking history).
7.Able to comply with all study procedures, including the use of study inhalers and spirometer
8.Provide written informed consent to participate in the study, indicated by a personal signature and date on the patient consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

Exclusion criteria

Patients who meet any of the following criteria will be excluded from participating in the study:
1.Evidence of any unstable or untreated clinically significant immunological, cardiac, cardiovascular, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormality or disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk during her/his participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study
2.Respiratory tract infection or COPD exacerbation not completely resolved within the last 2 weeks prior to the screening visit or between the screening and the randomization
3.Abnormality of inspiratory function (e.g. laryngeal obstruction, neuromuscular disease)
4.Need for daily oxygen therapy
5.Asthma, allergic rhinitis, cystic fibrosis, bronchiolitis obliterans, fibrosis, active or latent tuberculosis, a1-antitrypsin deficiency or any other causes of chronic airflow limitation apart from COPD
6.Use of any of the prohibited medications as detailed in the concomitant medication section
7.Patients with any sensitivity or allergy to any of the products used within this clinical trial
8.Female pregnant, breast-feeding or of childbearing potential age without efficient means of birth control (IUD, OCS, implants, hormonal patch, vaginal ring or spermicide and condom)
9.Patients with human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV)
10.Participation in any investigational medical studies within 2 month prior the screening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective<br>-To assess the non-inferiority between Tiotropium DPI capsule 8.8µg and Spiriva® 18µg Handihaler® by measurement of the bronchodilating effect<br>;Secondary Objective: •Secondary Objectives<br>-To assess and compare the safety of both products.<br>-To demonstrate a difference between the two dosages of SMB tiotropium <br>;Primary end point(s): Primary endpoint:<br><br>-Trough FEV1 response defined as change in FEV1 from baseline to FEV1 24h post-dose measurement <br>;Timepoint(s) of evaluation of this end point: Visit 2-Visit 3-Visit 4