Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

Phase 3

Completed

• Registration Number: CTRI/2009/091/000260
• Lead Sponsor: ovartis Health care Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 972

Inclusion Criteria

1.Male and female adults aged greater than or equal to 40 years, who have signed an Informed Consent Form prior to

initiation of any study related procedure

2. Co operative outpatients with a diagnosis of COPD (moderate to severe as classified by the

GOLD Guidelines, 2006) and including:

a) Smoking history of at least 20 pack years

b) Post-bronchodilator FEV1 less than 80 percent and greater than or equal to 30 percent of the predicted normal value

c) Post-bronchodilator FEV1 FVC less than 70 percent

Exclusion Criteria

1.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum fhuman chorionic gonadotrophin laboratory test (greater than 5 mIU per mL)

2. Women of child-bearing potential, defined as all women physiologically capable of

becoming pregnant, including women whose career, lifestyle, or sexual orientation

precludes intercourse with a male partner and women whose partners have been sterilized

by vasectomy or other means, UNLESS they meet the following definition of postmenopausal.

12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous

amenorrhea with serum FSH levels greater than40 mIU per mL or are using one or more of the

following acceptable methods of contraception.

a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)

b) hormonal contraception (implantable, patch, oral)

c) double-barrier methods (any double combination of. IUD, male or female condom

with spermicidal gel, diaphragm, sponge, cervical cap)

Acceptable methods of contraception may include total abstinence at the discretion of

the investigator in cases where the age, career, lifestyle, or sexual orientation of the

patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation,

symptothermal, post-ovulation methods) and withdrawal are not acceptable methods

of contraception. Reliable contraception should be maintained throughout the study

and for 30 days after study drug discontinuation

3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit

1 or during the run-in period

4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD

exacerbation). This is typically patients requiring oxygen therapy greater than15 h per day delivered

by home oxygen cylinder or concentrator.

5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients

who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue

from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the

start of the respiratory tract infection)

6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed

by chest x-ray to be no longer active) or clinically significant bronchiectasis

7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited

to).

a) blood eosinophil count greater than 400 per mm3

b) onset of respiratory symptoms prior to age 40 years

8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a

history of blood glucose levels consistently outside the normal range or HbA1C greater than 8.0 %

of total Hb measured at Visit 1

9. Patients who, in the judgment of the investigator or the responsible Novartis personnel,

have a clinically relevant laboratory abnormality or a clinically significant condition such

as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF),

uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia,

hyperadrenergic state or any condition which in the investigat

Study & Design

• Study Type: Interventional
• Study Design: Not specified