Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

NCT01012739 | Completed Phase 2 Results

• 2 other identifiers: CQAB149B22222009-012600-48
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 4

Brief Summary

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

Conditions

Asthma

Keywords

asthma; QAB149; indacaterol; pulmonary function

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment

  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 for each treatment.

  Baseline and Day 1

Secondary Outcomes (5)

• Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment

  Baseline and Day 1

• Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment

  From 5 minutes to 12 hours post-dose

• Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment

  From 5 minutes to 4 hours post-dose for each treatment

• Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment

  0 to 24 hours post-dose

• Indacaterol Exposure (Cmax) for Each Treatment

  0 to 24 hours post-dose

Study Arms (4)

Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg

EXPERIMENTAL

In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo

EXPERIMENTAL

In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg

EXPERIMENTAL

In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

EXPERIMENTAL

In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Interventions

Indacaterol 150 μg via the Concept1 dry-powder inhaler DRUG

Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg; Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg; Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo; Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Indacaterol 60 μg via the Simoon dry-powder inhaler DRUG

Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg; Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg; Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo; Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Indacaterol 120 μg via the Simoon dry-powder inhaler DRUG

Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg; Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg; Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo; Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Placebo to indacaterol via the Concept1 dry-powder inhaler DRUG

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg; Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg; Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo; Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%
• Patients using inhaled corticosteroid (with or without long-acting beta agonist)

You may not qualify if:

• Asthma exacerbations in previous 6 months
• Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
• Excessive use of short-acting beta agonists

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Groningen, Netherlands

Location

Novartis Investigative Site

Belfast, United Kingdom

Location

Novartis Investigative Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 29, 2011
• Results First Posted: August 17, 2011

Record last verified: 2011-08

Locations

DE (1); GB (2); NL (1)