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AsthmaPhase 2NCT00545272

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

A Phase 2 study testing indacaterol, formoterol and short acting β2-agonist in people with Asthma, run by Novartis Pharmaceuticals at 60 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 75 years
Conditions the study is for
Asthma
What is being tested?
indacaterol, formoterol and short acting β2-agonist
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
60 sitesin 10 countries
Study dates
Oct 2007to Apr 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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:
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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:
  • who's asthma is likely to deteriorate during the study (including seasonal allergy),
  • hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1,
  • who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1
Show all 9Show fewer
  • who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1
  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

Israel10 sites

  • Novartis Investigator Site

    Afula

  • Novartis Investigator Site

    Ashkelon

  • Novartis Investigator Site

    Beersheba

  • Novartis investigator site

    Haifa

  • Novartis investigator site

    Jerusalem

  • Novartis Investigator Site

    Petah Tikva

  • Novartis Investigator Site

    Rehovot

  • Novartis Investigator Site

    Tel Aviv

  • Novartis Investigator Site

    Tel-Hashorner

  • Novartis Investigator Site

    Zrifin

Other trials in Israel

Hungary8 sites

  • Novartis investigator site

    Balassagyarmat

  • Novartis Investigator Site

    Érd

  • Novartis Investigator site

    Füzesabony

  • Novartis Investigator Site

    Gyonggyos

  • Novartis Investigator Site

    Mosdoz

  • Novartis Investigator Site

    Pest

  • Novartis Investigator Site

    Siófok

  • Novartis Investigator Site

    Százhalombatta

Other trials in Hungary

South Africa8 sites

  • Novartis Investigator Site

    Bloernfontain

  • Novartis Investigator Site

    Cape Town

  • Novartis Investigator Site

    Johannesburg

  • Novartis Investigator Site

    Krugersdorp

  • Novartis Investigator Site

    Les Marais

  • Novartis Investigator Site

    Pretoria

  • Novartis Investigator Site

    Roodepoort

  • Novartis Investigator Site

    Themba

Other trials in South Africa

Germany7 sites

  • Novartis Investigator Site

    Aalen

  • Novartis Investigator Site

    Berlin

  • Novartis Investigator Site

    Braunschweig

  • Novartis Investigator Site

    Deggendorf

  • Novartis Investigator Site

    Fürstenwalde

  • Novartis Investigator Site

    Leipzig

  • novartis Investigator site

    München

Other trials in Germany

Czechia6 sites

  • Novartis Investigator Site

    Boskovice

  • Novartis Investigator site

    Břeclav

  • Novartis Investigator Site

    Brno

  • Novartis Investigator Site

    Liberec

  • Novartis Investigator Site

    Most

  • Novartis Investigator Site

    Tábor

Other trials in Czechia

Poland5 sites

  • Novartis Investigator Site

    Bialystok

  • Novartis investigator site

    Bydgoszcz

  • Novartis Investigator Site

    Lodz

  • Novartis Investigator site

    Lubin

  • Novartis Investigator Site

    Tarnów

Other trials in Poland

United Kingdom5 sites

  • Novartis Investigator Site

    Downpatrick

  • Novartis Investigator Site

    Glasgow

  • Novartis Investigator Site

    London

  • Novartis Investigator Site

    Southampton

  • Novartis Investigator Site

    Watford

Other trials in United Kingdom

Belgium4 sites

  • Novartis Investigator Site

    Aalst

  • Novartis Investigator Site

    Halen

  • Novartis Investigator Site

    Oostham

  • Novartis Investigator site

    Veurne

Other trials in Belgium

Russia4 sites

  • Novartis Investigator Site

    Moscow

  • Novartis Investigator Site

    Saint Petersburg

  • Novartis Investigator Site

    Smolensk

  • Novartis investigator site

    Tomsk

Other trials in Russia

Spain3 sites

  • Novartis Investigator Site

    Madrid

  • Novartis Investigator Site

    Pozuelo de Alacron

  • Novartis Investigator Site

    Valencia

Other trials in Spain

About this study

Official title: A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

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

Conditions
Asthma
Being tested
indacaterol, formoterol, placebo to indacaterol, placebo to formoterol, short acting β2-agonist
Keywords
QMF, indacaterol, Twisthaler®
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • indacaterolDrug

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

  • formoterolDrug

    Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.

  • placebo to indacaterolDrug

    Placebo TWISTHALER® device

  • placebo to formoterolDrug

    Placebo AEROLIZER® device

  • short acting β2-agonistDrug

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

Study groups in NCT00545272
Study groupRoleWhat they receive
indacaterol 62.5 μgExperimentalIndacaterol 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.
Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2-agonist
indacaterol 125 μgExperimentalIndacaterol 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.
Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2-agonist
indacaterol 250 μgExperimentalIndacaterol 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.
Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2-agonist
indacaterol 500 μgExperimentalIndacaterol 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.
Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2-agonist
formoterolActive comparatorFormoterol 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.
Receives: Drug: formoterol; Drug: placebo to indacaterol; Drug: short acting β2-agonist
placeboPlacebo comparatorPlacebo 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.
Receives: Drug: placebo to indacaterol; Drug: placebo to formoterol; Drug: short acting β2-agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.

    Measured: Baseline (prior to first dose) and Day 15 (24 hours after last dose)

Secondary outcomes (6)

  1. Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose

    FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.

    Measured: Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.

  2. The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.

    Measured: Day 1 Baseline (prior to first dose) and 24 hours post-dose.

  3. Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1

    FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.

    Measured: Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.

  4. Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.

    Measured: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose

  5. Change From Baseline in Morning and Evening Peak Expiratory Flow

    The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.

    Measured: Baseline (recorded during the screening period) and Days 1-14 (treatment period)

  6. Number of Participants Using Rescue Medication

    Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.

    Measured: Over 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545272
Sponsor's protocol ID
CQMF149A2201
Other IDs
2007-003191-19
Status last verified
Nov 2012
First submitted
16 Oct 2007
Last updated
18 Jan 2013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing indacaterol, formoterol and short acting β2-agonist in people with Asthma, run by Novartis Pharmaceuticals at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Israel, Hungary, South Africa, Germany, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline (prior to first dose) and Day 15 (24 hours after last dose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00545272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.

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