Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

NCT00999908 | Completed Phase 3 Results

• 2 other identifiers: CQAB149BIT012009-013763-19
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 11

Brief Summary

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; indacaterol; tiotropium

Outcome Measures

Primary Outcomes (1)

• Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment

  During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.

  4 hour period following inhalation of study treatment

Secondary Outcomes (2)

• Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment

  4 hour period following inhalation of study treatment

• Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment

  4 hour period following inhalation of study treatment

Study Arms (3)

Indacaterol 150 μg-tiotropium 18 μg-placebo

EXPERIMENTAL

Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo

Tiotropium 18 μg-placebo-indacaterol 150 μg

EXPERIMENTAL

Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo

Placebo-indacaterol 150 μg-tiotropium 18 μg

EXPERIMENTAL

Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg; Drug: Placebo

Interventions

Indacaterol 150 μg DRUG

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

Indacaterol 150 μg-tiotropium 18 μg-placebo; Placebo-indacaterol 150 μg-tiotropium 18 μg; Tiotropium 18 μg-placebo-indacaterol 150 μg

Tiotropium 18 μg DRUG

Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Indacaterol 150 μg-tiotropium 18 μg-placebo; Placebo-indacaterol 150 μg-tiotropium 18 μg; Tiotropium 18 μg-placebo-indacaterol 150 μg

Placebo DRUG

Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Indacaterol 150 μg-tiotropium 18 μg-placebo; Placebo-indacaterol 150 μg-tiotropium 18 μg; Tiotropium 18 μg-placebo-indacaterol 150 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 moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
• Smoking history of at least 10 pack-years.
• Forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 50% of the predicted normal value.
• Post-bronchodilator FEV1/Force vital capacity (FVC) \< 0.7.

You may not qualify if:

• Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
• Patients who have had a respiratory tract infection within 6 weeks prior to screening.
• Patients with concomitant pulmonary disease.
• Patients with alpha-1-antitrypsin deficiency.
• Patients with contraindications for tiotropium treatment.
• Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Bergamo, Italy

Location

Novartis Investigative Site

Brescia, Italy

Location

Novartis Investigative Site

Cava de' Tirreni, Italy

Location

Novartis Investigative Site

Genova, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Orbassano, Italy

Location

Novartis Investigative Site

Pavia, Italy

Location

Novartis Investigative Site

Reggio Emilia, Italy

Location

Novartis Investigative Site

Sesto San Giovanni, Italy

Location

Novartis Investigative Site

Treviso, Italy

Location

Novartis Investigative Site

Verona, Italy

Location

Related Publications (1)

• Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27.

  PMID: 22035851 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2009
• First Posted: October 22, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 17, 2016
• Results First Posted: August 19, 2011

Record last verified: 2016-02

Locations

IT (11)