To compare the effect of Tiotropium 5 ug and Olodaterol 5 ug in fixed dose combination over Tiotropium 5 ug in reducing Moderate to severe worsening of a disease in patients with severe to very severe Chronic Obstructive Pulmonary disease

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/03/005597
• Date of registration: 02-03-2015
• Prospective Registration: Yes
• Primary sponsor: BoehringerIngelheim
• Public title: To compare the effect of Tiotropium 5 ug and Olodaterol 5 ug in fixed dose combination over Tiotropium 5 ug in reducing Moderate to severe worsening of a disease in patients with severe to very severe Chronic Obstructive Pulmonary disease
• Scientific title: A randomised, double-blind, active controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium and olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease exacerbation in patients with severe to very severe COPD
• Date of first enrolment: 23-03-2015
• Target sample size: 7800
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10608
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia , Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam

Contacts

• Name: Mahesh Patil
• Affiliation: Boehringer-Ingelheim India Pvt Ltd

• Name: Dr Pratha Gokhale
• Affiliation: Boehringer-Ingelheim India Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female patients, 40 years of age or older.

2. All patients must have a diagnosis of COPD and must meet the following spirometric criteria stable airway obstruction with a documented post-bronchodilator FEV1 less than 60% of predicted normal and a post-bronchodilator FEV1/FVC less than 70% at Visit 1

3. Patients with a documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.

4. Investigator should also ascertain that the patient is symptomatically stable as defined by

ï?· no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4

weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1

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

years

6. Patients must be able to perform all trial related procedures at the investigator discretion

including technically acceptable and eligible pulmonary function test vital status follow-up in case of discontinuation until the predicted exit date and COPD exacerbation interview every 6 weeks in case of premature discontinuation

until the predicted exit date
Exclusion criteria: 1. Patients with a significant disease other than COPD; a significant disease is defined as a

disease which, in the opinion of the investigator, may put the patient at risk because of participation in the study

and influence the results of the study

and cause concern regarding the patientâ??s ability to participate in the study.

2. Patients with a, in the opinion of the investigator, clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine more than 2 times ULN will be excluded regardless of clinical condition

3. Patients with a current documented history of asthma. For patients with allergic rhinitis or

atopy, source documentation is required to verify that the patient does not have asthma

Patients with any of the following conditions

4. A diagnosis of thyrotoxicosis

5. A history of myocardial infarction within 6 months of screening visit.

6. Life-threatening cardiac arrhythmia, as judged by the Investigator.

7. Known active tuberculosis.

8. Any malignancy unless free of disease for at least 5 years however patients with treated basal cell

carcinoma or squamous cell skin cancers are allowed.

9. A history of cystic fibrosis.

10. Clinically relevant bronchiectasis, as judged by the Investigator

11. Patients with severe emphysema requiring endobronchial interventions within 6 months

prior to screening

5. A history of myocardial infarction within 6 months of screening visit (Visit 1).

6. Life-threatening cardiac arrhythmia, as judged by the Investigator.

7. Known active tuberculosis.

8. Any malignancy unless free of disease for at least 5 years (patients with treated basal cell

carcinoma or squamous cell skin cancers are allowed).

9. A history of cystic fibrosis.

10. Clinically relevant bronchiectasis, as judged by the Investigator

11. Patients with severe emphysema requiring endobronchial interventions within 6 months

prior to screening

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- severe to very severe Chronic Obstructive Pulmonary Disease

Intervention(s)

Intervention1: tiotropium 5 ug and olodaterol 5 ug in fixed dose combination: Respimat Inhaler Tiotropium and Olodaterol each in 5 ug combined as fixed dose combination
Once daily
For 52 weeks
Control Intervention1: Tiotropium 5 ug: Respimat Inhaler Tiotropium 5 ug once daily for 52 weeks will be given to patients in comparator arm

Primary Outcome(s)

Primary Endpoint

1. Annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date)

Secondary Endpoint

1. Time to first moderate to severe COPD exacerbation during the treatment period

2. Annualised rate of exacerbation leading to hospitalisation during the treatment period

3. Time to first COPD exacerbations leading to hospitalisation during the treatment period

4. Time to all-cause mortalityTimepoint: Primary Endpoint

52 weeks and 1 day



Secondary end point

52 weeks and 1 day

Secondary Outcome(s)

1. Time to first moderate to severe COPD exacerbation during the treatment period

2. Annualised rate of exacerbation leading to hospitalisation during the treatment period

3. Time to first COPD exacerbations leading to hospitalisation during the treatment period

4. Time to all-cause mortalityTimepoint: Primary Endpoint

52 weeks and 1 day

Secondary ID(s)

1237.19 Version 1 dated 29 Sep 2014

Source(s) of Monetary Support

Boehringer-Ingelheim India Pvt. Ltd., Mumbai.

Ethics review

Status: Approved
Approval date: 20/12/2014
Contact:

Institutional Human Ethics Committee, Bala Medical Center and Hospitals

Status: Approved
Approval date: 23/12/2014
Contact:

Getwell Institutional Ethics Committee

Status: Approved
Approval date: 30/12/2014
Contact:

Virtuos Institutional Medical Research Ethics Committee, Shreekrishna Hrudaya & critical care Centre Ltd

Status: Approved
Approval date: 20/11/2015
Contact:

Institutional Ethics Committee Asthma Bhavan

Status: Not Approved
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 Institutional Ethics Committee, SRM Medical College Hospital and Research Centre

Status: Not Approved
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AMC MET Ethics Committee

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Drug Trial Ethics Committee,Dayanand Medical college & hospital

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Eesha Institutional Ethics Committee

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SR Kalla Memorial Ethical Committee for Human Research

Results

• Date Completed: 21/03/2017