MedDataX Logo

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

NCT ID: NCT01484197

Last Updated: 2015-04-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Effects of Indacaterol Maleate (QAB149) as a New Formulation in the EPIC Test Fixture

NCT01845623

Asthma
WITHDRAWN PHASE2

Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

NCT03257995

Asthma
COMPLETED PHASE2

Efficacy and Safety of Different Doses of Indacaterol

NCT01079130

Asthma
COMPLETED PHASE3

Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

NCT01156844

Persistent Asthma
COMPLETED PHASE2

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

NCT01012739

Asthma
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

75 µg Indacaterol (LB) + Placebo (PoS)

75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Group Type EXPERIMENTAL

75 µg indacaterol maleate (LB)

Intervention Type DRUG

75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (PoS)

Intervention Type DRUG

Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

75 µg Indacaterol (PoS) + Placebo (LB)

75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Group Type EXPERIMENTAL

75 µg indacaterol maleate (PoS)

Intervention Type DRUG

75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (LB)

Intervention Type DRUG

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

37.5 µg Indacaterol (PoS) + Placebo (LB)

37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Group Type EXPERIMENTAL

37.5 µg indacaterol maleate (PoS)

Intervention Type DRUG

37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (LB)

Intervention Type DRUG

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Placebo (LB) and Placebo (PoS)

Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Group Type EXPERIMENTAL

placebo to indacaterol (LB)

Intervention Type DRUG

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

placebo to indacaterol (PoS)

Intervention Type DRUG

Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

75 µg indacaterol maleate (LB)

75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Intervention Type DRUG

75 µg indacaterol maleate (PoS)

75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Intervention Type DRUG

37.5 µg indacaterol maleate (PoS)

37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Intervention Type DRUG

placebo to indacaterol (LB)

Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

Intervention Type DRUG

placebo to indacaterol (PoS)

Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Wiesbaden, Germany, Germany

Site Status

Novartis Investigative Site

Machester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011-001825-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIDD001A2201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
NCT00927901 COMPLETED PHASE2
Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
NCT02892019 COMPLETED PHASE2
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
NCT00624702 COMPLETED PHASE1
Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma
NCT01959412 COMPLETED PHASE2
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma
NCT00556673 COMPLETED PHASE2
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
NCT00545272 COMPLETED PHASE2
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
NCT01609478 COMPLETED PHASE2
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
NCT00529529 COMPLETED PHASE3
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
NCT00557440 COMPLETED PHASE2
Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
NCT00096616 COMPLETED PHASE2
A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers
NCT02403713 COMPLETED PHASE1
A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients
NCT00702910 COMPLETED PHASE1
Controller Medications in the Management of Bronchial Asthma
NCT01055041 COMPLETED NA
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
NCT00605306 COMPLETED PHASE2
Phase 2a Study to Assess the Efficacy and Safety of AZD4604 in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
NCT06020014 COMPLETED PHASE2
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
NCT00130351 COMPLETED PHASE3
Bronchoprotective Effect of Arformoterol in Children With Exercise-Induced Bronchospasm (EIB)
NCT00662779 WITHDRAWN PHASE3
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
NCT00347139 COMPLETED PHASE2
Study to Evaluate the Pharmacokinetic Profile of Salbutamol Delivered by Unit Dose Dry Powder Inhaler (UD-DPI) Compared to the Diskus and Metered Dose Inhaler (MDI) in Healthy Volunteers.
NCT01984086 COMPLETED PHASE1
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
NCT00354666 COMPLETED PHASE2
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
NCT01641081 COMPLETED PHASE2
Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
NCT00736489 COMPLETED PHASE2
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
NCT04007198 COMPLETED PHASE1
Study to Investigate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Single & Repeat Doses of GSK2269557
NCT01462617 COMPLETED PHASE1
Evaluation of AZD8154 Concentrations in Blood
NCT04480879 TERMINATED PHASE1