AsthmaPhase 2NCT01012739

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

A Phase 2 study testing Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler and Indacaterol 120 μg via the Simoon dry-powder inhaler in people with Asthma, run by Novartis Pharmaceuticals at 4 sites in 3 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler and Indacaterol 120 μg via the Simoon dry-powder inhaler
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 4 sitesin 3 countries
Study dates: Oct 2009to Mar 2010
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%
Patients using inhaled corticosteroid (with or without long-acting beta agonist)

Who cannot join

Asthma exacerbations in previous 6 months
Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
Excessive use of short-acting beta agonists
Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

United Kingdom2 sites

Novartis Investigative Site
Belfast
Novartis Investigative Site
Manchester

Other trials in United Kingdom

Germany1 site

Novartis Investigative Site
Berlin

Other trials in Germany

Netherlands1 site

Novartis Investigative Site
Groningen

Other trials in Netherlands

About this study

Official title: A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

Read the detailed description

This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

Conditions: Asthma
Being tested: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler, Indacaterol 120 μg via the Simoon dry-powder inhaler, Placebo to indacaterol via the Concept1 dry-powder inhaler
Keywords: asthma, QAB149, indacaterol, pulmonary function
Medical subject headings: Asthma

What participants receive

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

Indacaterol 150 μg via the Concept1 dry-powder inhalerDrug
Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.
Indacaterol 60 μg via the Simoon dry-powder inhalerDrug
Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
Indacaterol 120 μg via the Simoon dry-powder inhalerDrug
Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
Placebo to indacaterol via the Concept1 dry-powder inhalerDrug
Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Study groups in NCT01012739
Study group	Role	What they receive
Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg	Experimental	In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler
Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo	Experimental	In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler
Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg	Experimental	In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler
Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg	Experimental	In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. Receives: Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler; Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

What is being measured

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

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.
Measured: Baseline and Day 1

Secondary outcomes (5)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.
Measured: Baseline and Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.
Measured: From 5 minutes to 12 hours post-dose
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Measured: From 5 minutes to 4 hours post-dose for each treatment
Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment
All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.
Measured: 0 to 24 hours post-dose
Indacaterol Exposure (Cmax) for Each Treatment
All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.
Measured: 0 to 24 hours post-dose

Timeline

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

Oct 2009Mar 2010

First posted13 Nov 2009 (estimated)
Study startOct 2009
Primary completionMar 2010
Study completionMar 2010

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 AsthmaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012739
Sponsor's protocol ID: CQAB149B2222
Other IDs: 2009-012600-48, 2009
Status last verified: Aug 2011
First submitted: 12 Nov 2009
Last updated: 29 Aug 2011
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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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device
ClinicalTrials.gov ID: NCT01012739
Acronym / sponsor ID: CQAB149B2222
Conditions: Asthma
Keywords: asthma, QAB149, indacaterol, pulmonary function
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 13 Nov 2009 (estimated)
Results: Posted 17 Aug 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg	Experimental	Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler, Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler, Drug: Placebo to indacaterol via the Concept1 dry-powder inhalerIn treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo	Experimental	Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler, Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler, Drug: Placebo to indacaterol via the Concept1 dry-powder inhalerIn treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg	Experimental	Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler, Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler, Drug: Placebo to indacaterol via the Concept1 dry-powder inhalerIn treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg	Experimental	Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler, Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler, Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler, Drug: Placebo to indacaterol via the Concept1 dry-powder inhalerIn treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50%
Patients using inhaled corticosteroid (with or without long-acting beta agonist)

Key exclusion criteria (4 listed)

Asthma exacerbations in previous 6 months
Chronic obstructive pulmonary disease (COPD) or other pulmonary disease
Excessive use of short-acting beta agonists
Other protocol-defined inclusion/exclusion criteria applied to the study.

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
Indacaterol 150 μg via the Concept1 dry-powder inhalerIndacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.	Drug	Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg, Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg, Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo, Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg
Indacaterol 60 μg via the Simoon dry-powder inhalerIndacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.	Drug	Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg, Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg, Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo, Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg
Indacaterol 120 μg via the Simoon dry-powder inhalerIndacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.	Drug	Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg, Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg, Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo, Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg
Placebo to indacaterol via the Concept1 dry-powder inhalerPlacebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.	Drug	Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg, Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg, Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo, Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Primary outcome

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment
Time frame: Baseline and Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.

5 secondary outcomes

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
Time frame: Baseline and Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
Time frame: From 5 minutes to 12 hours post-dose
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment
Time frame: From 5 minutes to 4 hours post-dose for each treatment
Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment
Time frame: 0 to 24 hours post-dose
Indacaterol Exposure (Cmax) for Each Treatment
Time frame: 0 to 24 hours post-dose

Results and safety

Results posted to the registry on 17 Aug 2011, 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 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg	9	9
Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo	8	8
Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg	9	9
Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg	9	8

Primary outcome: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment

Time frame: Baseline and Day 1. Mean (Standard Deviation). Unit: Liters

Measure	Indacaterol 150 μg n = 33	Indacaterol 60 μg n = 33	Indacaterol 120 μg n = 34	Placebo to Indacaterol n = 35
Value	2.97 (0.695)	2.93 (0.688)	2.91 (0.734)	2.77 (0.67)

Population analysed: Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.

5 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 150 μg	0 of 33 (0%)	19 of 33 (57.6%)	Not reported
Indacaterol 60 μg	0 of 33 (0%)	16 of 33 (48.5%)	Not reported
Indacaterol 120 μg	0 of 34 (0%)	21 of 34 (61.8%)	Not reported
Placebo to Indacaterol	0 of 35 (0%)	11 of 35 (31.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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 Pharmaceuticals study director

Novartis Pharmaceuticals

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom, Germany, Netherlands. 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. 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 17 Aug 2011). 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?

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment (time frame: Baseline and Day 1). 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 NCT01012739.

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 29 Aug 2011.