A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

NCT ID: NCT00545272

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-04-30

Brief Summary

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

indacaterol 62.5 μg

Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: EXPERIMENTAL

indacaterol

Intervention Type: DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type: DRUG

Placebo AEROLIZER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

indacaterol 125 μg

Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: EXPERIMENTAL

indacaterol

Intervention Type: DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type: DRUG

Placebo AEROLIZER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

indacaterol 250 μg

Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: EXPERIMENTAL

indacaterol

Intervention Type: DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type: DRUG

Placebo AEROLIZER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

indacaterol 500 μg

Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: EXPERIMENTAL

indacaterol

Intervention Type: DRUG

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

placebo to formoterol

Intervention Type: DRUG

Placebo AEROLIZER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

formoterol

Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: ACTIVE_COMPARATOR

formoterol

Intervention Type: DRUG

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

placebo to indacaterol

Intervention Type: DRUG

Placebo TWISTHALER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

placebo

Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Group Type: PLACEBO_COMPARATOR

placebo to indacaterol

Intervention Type: DRUG

Placebo TWISTHALER® device

placebo to formoterol

Intervention Type: DRUG

Placebo AEROLIZER® device

short acting β2-agonist

Intervention Type: DRUG

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Interventions

indacaterol

Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).

Intervention Type: DRUG

formoterol

Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

Intervention Type: DRUG

placebo to indacaterol

Placebo TWISTHALER® device

Intervention Type: DRUG

placebo to formoterol

Placebo AEROLIZER® device

Intervention Type: DRUG

short acting β2-agonist

100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB) approval), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient's parent / guardian.

2. Patients with asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:

1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.

2. Patients with a Forced Expiratory Volume in one second (FEV1) at Visit 1 of ≥50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.

3. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180 µg of salbutamol/albuterol Metered Dose Inhaler (MDI) (or equivalent dose of Dry Powder Inhaler [DPI]) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.

Exclusion Criteria

• Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years.
• Patients:

1. who's asthma is likely to deteriorate during the study (including seasonal allergy),

2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1,

3. who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1

4. who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1

5. Patients who require the use of ≥8 inhalations per day of short acting B2-agonist (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from Screening to Randomization.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharma

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Novartis Investigator Site

Aalst, , Belgium

Novartis Investigator Site

Halen, , Belgium

Novartis Investigator Site

Oostham, , Belgium

Novartis Investigator site

Veurne, , Belgium

Novartis Investigator Site

Boskovice, , Czechia

Novartis Investigator Site

Brno, , Czechia

Novartis Investigator site

Břeclav, , Czechia

Novartis Investigator Site

Liberec, , Czechia

Novartis Investigator Site

Most, , Czechia

Novartis Investigator Site

Tábor, , Czechia

Novartis Investigator Site

Aalen, , Germany

Novartis Investigator Site

Berlin, , Germany

Novartis Investigator Site

Braunschweig, , Germany

Novartis Investigator Site

Deggendorf, , Germany

Novartis Investigator Site

Fürstenwalde, , Germany

Novartis Investigator Site

Leipzig, , Germany

novartis Investigator site

München, , Germany

Novartis investigator site

Balassagyarmat, , Hungary

Novartis Investigator Site

Érd, , Hungary

Novartis Investigator site

Füzesabony, , Hungary

Novartis Investigator Site

Gyonggyos, , Hungary

Novartis Investigator Site

Mosdoz, , Hungary

Novartis Investigator Site

Pest, , Hungary

Novartis Investigator Site

Siófok, , Hungary

Novartis Investigator Site

Százhalombatta, , Hungary

Novartis Investigator Site

Afula, , Israel

Novartis Investigator Site

Ashkelon, , Israel

Novartis Investigator Site

Beersheba, , Israel

Novartis investigator site

Haifa, , Israel

Novartis investigator site

Jerusalem, , Israel

Novartis Investigator Site

Petah Tikva, , Israel

Novartis Investigator Site

Rehovot, , Israel

Novartis Investigator Site

Tel Aviv, , Israel

Novartis Investigator Site

Tel-Hashorner, , Israel

Novartis Investigator Site

Zrifin, , Israel

Novartis Investigator Site

Bialystok, , Poland

Novartis investigator site

Bydgoszcz, , Poland

Novartis Investigator Site

Lodz, , Poland

Novartis Investigator site

Lubin, , Poland

Novartis Investigator Site

Tarnów, , Poland

Novartis Investigator Site

Moscow, , Russia

Novartis Investigator Site

Saint Petersburg, , Russia

Novartis Investigator Site

Smolensk, , Russia

Novartis investigator site

Tomsk, , Russia

Novartis Investigator Site

Bloernfontain, , South Africa

Novartis Investigator Site

Cape Town, , South Africa

Novartis Investigator Site

Johannesburg, , South Africa

Novartis Investigator Site

Krugersdorp, , South Africa

Novartis Investigator Site

Les Marais, , South Africa

Novartis Investigator Site

Pretoria, , South Africa

Novartis Investigator Site

Roodepoort, , South Africa

Novartis Investigator Site

Themba, , South Africa

Novartis Investigator Site

Madrid, , Spain

Novartis Investigator Site

Pozuelo de Alacron, , Spain

Novartis Investigator Site

Valencia, , Spain

Novartis Investigator Site

Downpatrick, , United Kingdom

Novartis Investigator Site

Glasgow, , United Kingdom

Novartis Investigator Site

London, , United Kingdom

Novartis Investigator Site

Southampton, , United Kingdom

Novartis Investigator Site

Watford, , United Kingdom

Countries

Belgium; Czechia; Germany; Hungary; Israel; Poland; Russia; South Africa; Spain; United Kingdom

Other Identifiers

2007-003191-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQMF149A2201

Identifier Type: -

Identifier Source: org_study_id