A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00622635 | Completed Phase 3 Results

• 1 other identifier: CQAB149B2340
• Study Type: interventional
• Target: 68
• Locations: 3 countries
• Sites: 14

Brief Summary

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; indacaterol

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 15)

  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 each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.

  After 14 days

Secondary Outcomes (19)

• Forced Expiratory Volume in 1 Second (FEV1) 5 Minutes Post-dose at the End of Each Treatment Period (Day 14)

  5 minutes post-dose at the end of each treatment period (Day 14)

• Forced Expiratory Volume in 1 Second (FEV1) 15 Minutes Post-dose at the End of Each Treatment Period (Day 14)

  15 minutes post-dose at the end of each treatment period (Day 14)

• Forced Expiratory Volume in 1 Second (FEV1) 30 Minutes Post-dose at the End of Each Treatment Period (Day 14)

  30 minutes post-dose at the end of each treatment period (Day 14)

• Forced Expiratory Volume in 1 Second (FEV1) 1 Hour Post-dose at the End of Each Treatment Period (Day 14)

  1 hour post-dose at the end of each treatment period (Day 14)

• Forced Expiratory Volume in 1 Second (FEV1) 2 Hours Post-dose at the End of Each Treatment Period (Day 14)

  2 hours post-dose at the end of each treatment period (Day 14)

Study Arms (6)

Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg

EXPERIMENTAL

In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg

EXPERIMENTAL

In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol

EXPERIMENTAL

In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg

EXPERIMENTAL

In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol

EXPERIMENTAL

In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg

EXPERIMENTAL

In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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; Drug: Placebo to indacaterol; Drug: Salmeterol 50 μg

Interventions

Indacaterol 300 μg DRUG

Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).

Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg; Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol; Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg; Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg; Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol; Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg

Placebo to indacaterol DRUG

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

Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg; Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol; Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg; Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg; Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol; Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg

Salmeterol 50 μg DRUG

Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).

Indacaterol 300 μg - placebo to indacaterol - salmeterol 50 μg; Indacaterol 300 μg - salmeterol 50 μg - placebo to indacaterol; Placebo to indacaterol - indacaterol 300 μg - salmeterol 50 μg; Placebo to indacaterol - salmeterol 50 μg - indacaterol 300 μg; Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol; Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
• Smoking history of at least 20 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 been hospitalized 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 or randomization 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigator Site

Normal, Illinois, United States

Location

Novartis Investigator Site

Shawnee Mission, Kansas, United States

Location

Novartis Investigator Site

Lafayette, Louisiana, United States

Location

Novartis Investigator Site

Charlotte, North Carolina, United States

Location

Novartis Investigator Site

Raleigh, North Carolina, United States

Location

Novartis Investigator site

Cincinnati, Ohio, United States

Location

Novartis Investigator Site

Spartanburg, South Carolina, United States

Location

Novartis Investigator Site

Genk, Belgium

Location

Novartis Investigator Site

Hasselt, Belgium

Location

Novartis Investigator Site

Herentals, Belgium

Location

Novartis Investigator Site

Alicante, Spain

Location

Novartis Investigator site

Alzira, Spain

Location

Novartis Investigator Site

Madrid, Spain

Location

Novartis Investigator site

Mataró, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 25, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 18, 2011
• Results First Posted: August 18, 2011

Record last verified: 2011-07

Locations

ES (4); BE (3); US (7)