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

Asthma Clinical Trial

Official title:

A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012739
• Other study ID #: CQAB149B2222
• Secondary ID: 2009-012600-48
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2009
• Last updated: August 25, 2011
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Description:

This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• 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)

Exclusion criteria:

• Asthma exacerbations in previous 6 months

• Chronic obstructive pulmonary disease (COPD) or other pulmonary disease

• Excessive use of short-acting beta agonists

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Indacaterol 150 µg via the Concept1 dry-powder inhaler
Indacaterol maleate 150 µg was provided in powder filled capsules with the Concept1 dry-powder inhaler.
• Indacaterol 60 µg via the Simoon dry-powder inhaler
Indacaterol 60 µg was provided in powder filled capsules with the Simoon dry-powder inhaler.
• Indacaterol 120 µg via the Simoon dry-powder inhaler
Indacaterol 120 µg was provided in powder filled capsules with the Simoon dry-powder inhaler.
• Placebo to indacaterol via the Concept1 dry-powder inhaler
Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin
Netherlands	Novartis Investigative Site	Groningen
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.	Baseline and Day 1	No
Secondary	Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.	From 5 minutes to 12 hours post-dose	No
Secondary	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	FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.	From 5 minutes to 4 hours post-dose for each treatment	No
Secondary	Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment	All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.	0 to 24 hours post-dose	No
Secondary	Indacaterol Exposure (Cmax) for Each Treatment	All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.	0 to 24 hours post-dose	No