Chronic obstructive pulmonary disease (bronchodilating effect) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: TIOTROPIUM 8.8 µg DPI
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TIOTROPIUM BROMIDE ANHYDROUS
Other descriptive name: ANHYDROUS TIOTROPIUM BROMIDE
Concentration unit: µg mic
Sponsors
Laboratoires SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective - To assess the non-inferiority between Tiotropium DPI capsule 8.8µg and Spiriva® 18µg Handihaler® by measurement of the bronchodilating effect ;Secondary Objective: • Secondary Objectives - To assess and compare the safety of both products. - To demonstrate a difference between the two dosages of SMB tiotropium ;Primary end point(s): Primary endpoint: -Trough FEV1 response defined as change in FEV1 from baseline to FEV1 24h post-dose measurement ;Timepoint(s) of evaluation of this end point: Visit 2-Visit 3-Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?Secondary parameters: Efficacy endpoint: - Peak bronchodilatory effect (FEV1 max) - Tmax of FEV1 - Baseline-adjusted area under the curve (AUC) for FEV1 over 24 hours post dosing - PEF max - Baseline adjusted AUC of PEF from 0 to 24 hours post dosing - Change in PEF at 24 hours post dose from baseline - FEV1 % max - Baseline adjusted AUC of FEV1% from 0 to 24 hours post dosing - Change in FEV1% at 24 hours post dose from baseline - FVC max - Baseline adjusted AUC of FVC from 0 to 24 hours post dosing - Change in FVC at 24 hours post dose from baseline - Partial baseline adjusted AUC for FEV1 from 0 to 4 hours post dose - Partial baseline adjusted AUC for FEV1 from 4 to 8 hours post dose - Partial baseline adjusted AUC for FEV1 from 8 to 12 hours post dose - Partial baseline adjusted AUC for FEV1 from 12 to 24 hours post dose Safety endpoints: - Adverse events - Physical examination - Vital signs - 12-lead ECG data ;Timepoint(s) of evaluation of this end point: Visit 1-Visit 2-Visit 3-Visit 4 | — |
Countries
Bulgaria, North Macedonia
Contacts
Public ContactClinical Trial Department
Laboratoires SMB S.A.
Outcome results
None listed