NCT00792805

Brief Summary

This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_3

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 17, 2011

Completed
Last Updated

August 17, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

November 17, 2008

Results QC Date

July 22, 2011

Last Update Submit

July 22, 2011

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPDindacaterollong-acting β2-agonistadults

Outcome Measures

Primary Outcomes (1)

  • Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.

    Week 12 + 1 day, Day 85

Study Arms (3)

Indacaterol 150 μg

EXPERIMENTAL

Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 150 µg

Indacaterol 300 μg

EXPERIMENTAL

Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Indacaterol 300 μg

Placebo to indacaterol

PLACEBO COMPARATOR

Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Drug: Placebo to indacaterol

Interventions

Indacaterol 150 µgDRUG

Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Indacaterol 150 μg
Indacaterol 300 μgDRUG

Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Indacaterol 300 μg
Placebo to indacaterolDRUG

Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Placebo to indacaterol

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged ≥ 40 years
  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
  • Smoking history of at least 10 pack years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

You may not qualify if:

  • Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
  • Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
  • Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening is prolonged
  • Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
  • Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novartis Investigative Site

Adelaide, Australia

Location

Novartis Investigative Site

Clayton, Australia

Location

Novartis Investigative Site

Daw Park, Australia

Location

Novartis Investigative Site

Beijing, China

Location

Novartis Investigative Site

Changsha, China

Location

Novartis Investigative Site

Chongqing, China

Location

Novartis Investigator Site

Fuzhou, China

Location

Novartis Investigative Site

Guangzhou, China

Location

Novartis Investigative Site

Shandong, China

Location

Novartis Investigative Site

Shanghai, China

Location

Novartis Investigative Site

Shenyang, China

Location

Novartis Investigative Site

Shijiazhuang, China

Location

Novartis Investigative Site

Xi'an, China

Location

Novartis Investigative Site

Bangalore, India

Location

Novartis Investigative Site

Trivandrum, India

Location

Related Publications (1)

  • Yao W, Wang C, Zhong N, Han X, Wu C, Yan X, Chen P, Yang W, Henley M, Kramer B. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study. Respirology. 2014 Feb;19(2):231-238. doi: 10.1111/resp.12211. Epub 2014 Jan 3.

    PMID: 24383720DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

November 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 17, 2011

Results First Posted

August 17, 2011

Record last verified: 2011-07

Locations

CN(10)IN(2)AU(3)