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OpenTrials
Completed

NCT Number: NCT01012739

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

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 120 μg via the Simoon dry-powder inhaler

Drug

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

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.

Primary outcomes

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

    Time frame: Baseline and Day 1

    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.

Secondary outcomes

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

    Time frame: Baseline and Day 1

    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.

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

    Time frame: From 5 minutes to 12 hours post-dose

    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.

  3. 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

    Time frame: 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.

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

    Time frame: 0 to 24 hours post-dose

    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.

  5. Indacaterol Exposure (Cmax) for Each Treatment

    Time frame: 0 to 24 hours post-dose

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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