Trial conducted to check Assessment of safety and efficacy for COPD patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/04/002557
• Date of registration: 10-04-2012
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim India Pvt Ltd
• Public title: Trial conducted to check Assessment of safety and efficacy for COPD patients
• Scientific title: A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 μg / 5 μg; 5 μg / 5 μg) (delivered by the RESPIMAT) compared with the individual components (2.5 μg and 5 μg tiotropium, 5 μg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1]
• Date of first enrolment: 18-04-2012
• Target sample size: 2500
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4204
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hungary, India, Japan, Netherlands, New Zealand, Norway, Portugal, Slovakia, South Africa, Spain, Taiwan, United States of America

Contacts

• Name: Shoma Das
• Affiliation: Boehringer-Ingelheim India Pvt Ltd

• Name: Shoma Das
• Affiliation: Boehringer-Ingelheim India Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior

to participation in the trial, which includes medication washout and restrictions.

2. All patients must have a diagnosis of COPD [P10-01267] and must meet the

following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator

FEV1 < 80% of predicted normal (ECSC, [R94-1408]; GOLD II - IV, [P10-01267] and

a post-bronchodilator FEV1/FVC <70% at Visit 1 (See Appendix 10.3 for ECSC

predicted normal equations).

3. Male or female patients, 40 years of age or older.

4. Patients must be current or ex-smokers with a smoking history of more than 10 pack

years. (see Appendix 10.3 for calculation):

Patients who have never smoked cigarettes must be excluded.

5. Patients must be able to

• perform technically acceptable pulmonary function tests ,

• perform technically acceptable PEF measurements,

• maintain records (Patient Daily e-Diary) during the study period ,

• perform all other assessments (e.g. complete self administed questionnaires),

as required in the protocol.

6. Patients must be able to inhale medication in a competent manner from the

RESPIMAT inhaler
Exclusion criteria: Patients with a significant disease other than COPD

Patients with a history of asthma.

A diagnosis of thyrotoxicosis

A diagnosis of paroxysmal tachycardia (100 beats per minute) (due to the known class side effect profile of Ã?2-agonists).

A history of myocardial infarction within 1 year of screening visit (Visit 1).

Unstable or life-threatening cardiac arrhythmia.

Hospitalization for heart failure within the past year.

Patients who regularly use daytime oxygen therapy for more than one hour per day

Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).

Pregnant or nursing women.

Women of childbearing potential not using a highly effective method of birth control.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Chronic Obstructive Pulmonary Disorder

Intervention(s)

Intervention1: Tiotropium+olodaterol 2.5 µg /5 µg combination: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks
Intervention2: Tiotropium+olodaterol 5 µg /5 µg combination: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks
Control Intervention1: Olodaterol (5 μg) inhalation solution: Route of administration: Oral inhalation via RESPIMAT inhaler
Dosage regimen: 2 inhalations once daily
Duration of Therapy: 52 weeks
Control Intervention2: Olodaterol and Tiotropium: Olodaterol 5 µg
Tiotropium 2.5 µg
Tiotropium 5 µg

Route of administration: Oral inhalation via RESPIMAT inhaler
Dosage regimen: 2 inhalations once daily
Duration of Therapy: 52 weeks
Control Intervention3: Tiotropium 2.5 µg: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks
Control Intervention4: Tiotropium 5 µg: Route of administration: Oral inhalation via RESPIMAT inhaler Dosage regimen: 2 inhalations once daily Duration of Therapy: 52 weeks

Primary Outcome(s)

â?¢ FEV1 AUC0-3h response

â?¢ Trough FEV1 response

â?¢ SGRQ (total score) (Combined data from 1237.5 and1237.6)

Timepoint: 24 weeks

Secondary Outcome(s)

The TDI focal score (to measure the effect of tiotropium plus olodaterol combination on patientsâ?? health-related quality of life) is key secondary endpoint (Combined data from 1237.5 and1237.6)

Timepoint: 24 weeks

Secondary ID(s)

1237.5,Version no 1.0 dated 11 May 2011

2009-010668-40

Source(s) of Monetary Support

Boehringer Ingelheim India Pvt Ltd

Ethics review

Status: Approved
Approval date: 20/02/2012
Contact:

Sujlam Independent Ethics Committee, Ahmedabad, Dr. Raj Bhagat

Status: Not Approved
Approval date:
Contact:

Bangalore Central Ethics Committee, Bangalore, Dr. Satish

Status: Not Approved
Approval date:
Contact:

Ethics Committee,Allergy Asthma Associates; Mysore; Dr.Mahesh P.A

Status: Not Approved
Approval date:
Contact:

Independent ethics Committee, Pune, Dr. Sundeep Salvi

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Review Board; St.Johns Medical College & Hospital

Status: Not Approved
Approval date:
Contact:

KMCH Ethics Committee, Kovai Medical Centre

Status: Not Approved
Approval date:
Contact:

Maarg Ethics Committee, Hyderabad, Dr. Pradyut Waghray

Status: Not Approved
Approval date:
Contact:

SMS Ethics committee; SMS Jaipur

Status: Not Approved
Approval date:
Contact:

Swasthya kalyan Ethics committee, Jaipur, Dr. Sharad Thikkiwal