COPDPhase 2NCT00557466

A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing indacaterol, formoterol and short acting β2- agonist in people with COPD, run by Novartis at 75 sites in 17 countries.

Completed

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

Official record

Search all trials

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 40 years and older
Conditions the study is for: COPD
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: 568 participants
Where: 75 sitesin 17 countries
Study dates: Oct 2007to May 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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
Smoking history of at least 10 pack years
Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.
Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

Who cannot join

Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
Patients with a history of asthma.
Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

75 sites in 17 countries.

Country

City, postcode or hospital

75 sites in 17 countries

Germany11 sites

Novartis Investigator Site
Berlin
Novartis Investigator site
Bibertal
Novartis Investigator Site
Bochum
Novartis Investigator Site - 2 sites
Bonn
Novartis Investigator Site
Cologne
Novartis Investigator Site
Frankfurt
Novartis Investigator Site
Hamburg
Novartis Investigator Site
Heidelberg
novartis Investigator site
Koblenz
Novartis Investigator Site
Marburg
Novartis Investigator Site
Solingen

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South Africa10 sites

Novartis Investigator Site
Bloemfontain
Novartis Investigator Site
Bloemfontein
Novartis Investigator Site
Cape Town
Novartis Investigator Site
Durban
Novartis Investigator Site
eManzimtoti
Novartis Investigator Site
George
Novartis Investigator Site
Johannesburg
Novartis Investigator Site
Port Elizabeth
Novartis Investigator Site
Pretoria
Novartis Investigator Site
Tygerberg

Other trials in South Africa

Turkey (Türkiye)9 sites

Novartis Investigator Site
Erzurum
Novartis Investigator Site
Isparta
Novartis Investigator Site
Istanbul
Novartis Investigator Site
Kahramanmaraş
Novartis Investigator Site
Kayseri
Novartis Investigator Site
Malatya
Novartis Investigator Site
Manisa
Novartis Investigator Site
Sanliurfa
Novartis Investigator Site
Trabzon

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Poland8 sites

Novartis Investigator Site
Izabelin
Novartis Investigator Site
Lodz
Novartis Investigator Site
Lublin
Novartis Investigator site
Mrozy
Novartis Investigator Site
Olsztyn
Novartis Investigator Site
Rzeszów
Novartis Investigator Site
Wejhrowo
Novartis Investigator Site
Włocławek

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United Kingdom7 sites

Novartis Investigator Site
Belfast
Novartis Investigator Site
Chesterfield
Novartis Investigator Site
Glasgow
Novartis Investigator Site
Plymouth
Novartis Investigator Site
Warminster
Novartis investigator site
Watford
Novartis Investigator Site
Whitstable

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France6 sites

Novartis Investigator Site
Bois-Guillaume
Novartis Investigator Site
Clermot Ferand
Novartis Investigator Site
Lille
Novartis Investigator Site
Marseille
Novartis Investigator Site
Nantes
Novartis Investigator site
Toulouse

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Romania4 sites

Novartis Investigator Site
Bucharest
Novartis Investigator Site
Cluj-Napoca
Novartis Investigator Site
Iași
Novartis Investigator Site
Timișoara

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Argentina3 sites

Novartis Investigator site
Buenos Aires
Novartis Investigator Site
Rosario
Novartis Investigator Site
Santillán

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Hungary3 sites

Novartis Investigator Site
Budapest
Novartis Investigator Site
Debrecen
Novartis investigator site
Pécs

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Italy3 sites

Novartis Investigator Site
Genova
Novartis Investigator Site
Naples
Novartis Investigator Site
Pordenone

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Lithuania3 sites

Novartis Investigator Site
Kaunas
Novartis Investigator Site
Klaipėda
Novartis Investigator Site
Vilnius

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Chile2 sites

Novartis Investigator Site
Santiago
Novartis Investigator Site
Val Pariso

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Latvia2 sites

Novartis investigator site
Daugavpils
Novartis Investigator Site
Riga

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Belgium1 site

Novartis Investigator Site
Liège

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Ireland1 site

Novartis investigator site
Dublin

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Norway1 site

Novartis Investigator Site
Tronheim

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Peru1 site

Novartis Investigator Site
Lima

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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 Patients With COPD

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

Conditions: COPD
Being tested: indacaterol, formoterol, placebo to indacaterol, placebo to formoterol, short acting β2- agonist
Keywords: QMF, indacaterol, TWISTHALER® device
Medical subject headings: Pulmonary Disease, Chronic Obstructive

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 NCT00557466
Study group	Role	What they receive
indacaterol 62.5 μg	Experimental	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. Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2- agonist
indacaterol 125 μg	Experimental	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. Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2- agonist
Indacaterol 250 μg	Experimental	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. Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2- agonist
indacaterol 500 μg	Experimental	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. Receives: Drug: indacaterol; Drug: placebo to formoterol; Drug: short acting β2- agonist
formoterol	Active comparator	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. Receives: Drug: formoterol; Drug: placebo to indacaterol; Drug: short acting β2- agonist
placebo	Placebo comparator	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. 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.

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)

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 and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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.
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 and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
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
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 prior to taking study medication and recorded measurements in a diary every morning and evening during the study. 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).
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.

Oct 2007May 2008

First posted14 Nov 2007 (estimated)
Study startOct 2007
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00557466
Sponsor's protocol ID: CQMF149B2201
Status last verified: Nov 2012
First submitted: 13 Nov 2007
Last updated: 18 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Patients With COPD
ClinicalTrials.gov ID: NCT00557466
Acronym / sponsor ID: CQMF149B2201
Conditions: COPD
Keywords: QMF, indacaterol, TWISTHALER® device
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 568 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Schering-Plough
Study start: Oct 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 14 Nov 2007 (estimated)
Results: Posted 18 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
indacaterol 62.5 μg	Experimental	Drug: indacaterol, Drug: placebo to formoterol, Drug: short acting β2- agonistIndacaterol 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.
indacaterol 125 μg	Experimental	Drug: indacaterol, Drug: placebo to formoterol, Drug: short acting β2- agonistIndacaterol 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.
Indacaterol 250 μg	Experimental	Drug: indacaterol, Drug: placebo to formoterol, Drug: short acting β2- agonistIndacaterol 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.
indacaterol 500 μg	Experimental	Drug: indacaterol, Drug: placebo to formoterol, Drug: short acting β2- agonistIndacaterol 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.
formoterol	Active comparator	Drug: formoterol, Drug: placebo to indacaterol, Drug: short acting β2- agonistFormoterol 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.
placebo	Placebo comparator	Drug: placebo to indacaterol, Drug: placebo to formoterol, Drug: short acting β2- agonistPlacebo 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

Key exclusion criteria (6 listed)

Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
Patients with a history of asthma.
Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
indacaterolIndacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).	Drug	Indacaterol 250 μg, indacaterol 125 μg, indacaterol 500 μg, indacaterol 62.5 μg
formoterolFormoterol delivered by oral inhalation via AEROLIZER® inhalation device.	Drug	formoterol
placebo to indacaterolPlacebo TWISTHALER® device	Drug	formoterol, placebo
placebo to formoterolPlacebo AEROLIZER® device	Drug	Indacaterol 250 μg, indacaterol 125 μg, indacaterol 500 μg, indacaterol 62.5 μg, placebo
short acting β2- agonist100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).	Drug	Indacaterol 250 μg, formoterol, indacaterol 125 μg, indacaterol 500 μg, indacaterol 62.5 μg, placebo

Primary outcome

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)
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.

6 secondary outcomes

Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
Time frame: Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
Time frame: Day 1 Baseline (prior to first dose) and 24 hours post-dose.
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
Time frame: Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose.
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Time frame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
Change From Baseline in Morning and Evening Peak Expiratory Flow
Time frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period).
Number of Participants Using Rescue Medication
Time frame: Over 14 days

Results and safety

Results posted to the registry on 18 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indacaterol 62.5 μg	98	94
Indacaterol 125 μg	92	87
Indacaterol 250 μg	101	95
Indacaterol 500 μg	96	92
Formoterol	90	87
Placebo	91	85

Primary outcome: 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). Least squares mean (Standard Error). Unit: liters

Measure	Indacaterol 62.5 μg n = 92	Indacaterol 125 μg n = 85	Indacaterol 250 μg n = 90	Indacaterol 500 μg n = 89	Formoterol n = 83	Placebo n = 80
Value	0.051 (0.0207)	0.073 (0.0217)	0.076 (0.0210)	0.121 (0.0211)	0.098 (0.0219)	0.005 (0.0223)

Population analysed: The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 62.5 μg	1 of 98 (1%)	4 of 98 (4.1%)	Not reported
Indacaterol 125 μg	0 of 92 (0%)	5 of 92 (5.4%)	Not reported
Indacaterol 250 μg	1 of 101 (1%)	3 of 101 (3%)	Not reported
Indacaterol 500 μg	2 of 96 (2.1%)	4 of 96 (4.2%)	Not reported
Formoterol	1 of 90 (1.1%)	6 of 90 (6.7%)	Not reported
Placebo	1 of 91 (1.1%)	8 of 91 (8.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharma AG study chair

Novartis Pharmaceuticals

75 sites in 17 countries: see every site and its status.

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 COPD, run by Novartis at 75 sites in 17 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 6 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 75 sites in Germany, South Africa, Turkey (Türkiye), Poland, United Kingdom and 12 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 NCT00557466.

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.