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A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01484197
First received: November 15, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.


Condition Intervention Phase
Asthma
 Drug: Indacaterol Maleate (high dose; Form 1) and Placebo (Form 2)
Drug: Placebo (Form 1) and Indacaterol Maleate (high dose; Form 2)
Drug: Placebo (Form 1) and Indacaterol Maleate (low dose; Form 2)
Drug: Placebo (Form 1) and Placebo (Form 2)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in forced expiratory volume in one second (FEV1) following 7 days of treatment [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of once-daily indacaterol in 2 different formulations in comparison to placebo in terms of the number and percentage of adverse events, clinically significant abnormalities in safety labs, electrocardiograms and relevant changes in blood pressure


Enrollment: 36
Study Start Date: November 2011
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol Maleate high dose and placebo 2
Indacaterol Maleate high dose and placebo 2
 Drug: Indacaterol Maleate (high dose; Form 1) and Placebo (Form 2)
Experimental: Indacaterol Maleate High dose plus placebo 1
Indacaterol Maleate High dose plus placebo 1
 Drug: Placebo (Form 1) and Indacaterol Maleate (high dose; Form 2)
Experimental: Indacaterol Maleate low dose and placebo 1
Indacaterol Maleate low dose and placebo 1
 Drug: Placebo (Form 1) and Indacaterol Maleate (low dose; Form 2)
Experimental: Placebo 1 and Placebo 2
Placebo 1 and Placebo 2
 Drug: Placebo (Form 1) and Placebo (Form 2)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with asthma
  • Aged 18 or above
  • Patients using inhaled corticosteroid (with or without long acting beta agonist)
  • Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

  • Asthma exacerbations in previous 6 months
  • COPD or other pulmonary disease
  • Excessive use of short acting beta agonists
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484197

Locations
Germany
Novartis Investigative site
Wiesbaden, Germany, 65187
United Kingdom
Novartis Investigative Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01484197     History of Changes
Other Study ID Numbers: CIDD001A2201, 2011-001825-25
Study First Received: November 15, 2011
Last Updated: July 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Asthma
Indacaterol
QAB149

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013