Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00615030

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 7 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

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full 24-h time period Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Indacaterol and Salmeterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 7 sitesin 3 countries
Study dates: Jan 2008to Aug 2008
Phase: Phase 3
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
Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
Smoking history of at least 20 pack years
Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

Who cannot join

Pregnant or lactating females
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long term oxygen therapy (>15 h a day)
Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
Patients with history of asthma (with further criteria)

Show all 16Show fewer

Patients with Type I or uncontrolled type II diabetes.
Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
Patient with a history with long QT syndrome or whose QTc interval is prolonged
Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
Patients who have had treatment with an investigational drug (with further criteria)
Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
Patients with known history of non compliance to medication
Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Germany4 sites

Novartis Investigative Site
Berlin
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Mainz

Other trials in Germany

France2 sites

Novartis Investigative Site
Beuvry
Novartis Investigative Site
Nantes

Other trials in France

Spain1 site

Novartis Investigative Site
Barcelona

Other trials in Spain

About this study

Official title: A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Indacaterol, Salmeterol, Placebo to Indacaterol, Placebo to Salmeterol
Keywords: COPD, bronchodilator, long acting beta agonist, LABA
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
Also called QAB149
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
SalmeterolDrug
Also called Serevent®
50 µg twice daily delivered via dry powder inhaler (DPI)
Placebo to IndacaterolDrug
Placebo matching indacaterol was delivered via SDDPI.
Placebo to SalmeterolDrug
Placebo matching salmeterol was delivered via DPI

Study groups in NCT00615030
Study group	Role	What they receive
Indacaterol Morning,Indacaterol Evening, Salmeterol	Experimental	In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Indacaterol Evening,Indacaterol Morning, Placebo	Experimental	In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Salmeterol, Placebo, Indacaterol Morning	Experimental	In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Placebo, Salmeterol, Indacaterol Evening	Experimental	In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Indacaterol Morning, Placebo, Indacaterol Evening	Experimental	In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Indacaterol Evening,Salmeterol, Indacaterol Morning	Experimental	In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Salmeterol, Indacaterol Evening, Placebo	Experimental	In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Placebo, Indacaterol Morning, Salmeterol	Experimental	In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Indacaterol Morning, Salmeterol, Placebo	Experimental	In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Indacaterol Evening, Placebo, Salmeterol	Experimental	In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry powder inhaler DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Salmeterol, Indacaterol Morning, Indacaterol Evening	Experimental	In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Placebo, Indacaterol Evening, Indacaterol Morning	Experimental	In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol

What is being measured

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

Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate.
The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Measured: After 14 days of treatment

Secondary outcomes (1)

Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. On the morning and evening of Day 15 trough FEV1 (i.e. mean of measurements performed 23 h 10 min and 23 h 45 min post-dose) were assessed. An analysis of covariance (ANCOVA) model was used with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.
Measured: After 14 days of dosing

Timeline

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

Jan 2008Aug 2008

First posted14 Feb 2008 (estimated)
Study startJan 2008
Primary completionJul 2008
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615030
Sponsor's protocol ID: CQAB149B2305
Status last verified: Jul 2011
First submitted: 1 Feb 2008
Last updated: 17 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Magnussen H, Verkindre C, Jack D, Jadayel D, Henley M, Woessner R, Higgins M, Kramer B; INPUT study investigators. Indacaterol once-daily is equally effective dosed in the evening or morning in COPD. Respir Med. 2010 Dec;104(12):1869-76. doi: 10.1016/j.rmed.2010.08.010. Epub 2010 Sep 20.
PubMed 20850959

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?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control
ClinicalTrials.gov ID: NCT00615030
Acronym / sponsor ID: CQAB149B2305
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, bronchodilator, long acting beta agonist, LABA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jul 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 14 Feb 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, care provider)
Number of arms: 12

Arm	Type	Receives
Indacaterol Morning,Indacaterol Evening, Salmeterol	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol Evening,Indacaterol Morning, Placebo	Experimental	Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Salmeterol, Placebo, Indacaterol Morning	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Placebo, Salmeterol, Indacaterol Evening	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol Morning, Placebo, Indacaterol Evening	Experimental	Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol Evening,Salmeterol, Indacaterol Morning	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Salmeterol, Indacaterol Evening, Placebo	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Placebo, Indacaterol Morning, Salmeterol	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol Morning, Salmeterol, Placebo	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Indacaterol Evening, Placebo, Salmeterol	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry powder inhaler DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Salmeterol, Indacaterol Morning, Indacaterol Evening	Experimental	Drug: Indacaterol, Drug: Salmeterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
Placebo, Indacaterol Evening, Indacaterol Morning	Experimental	Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to SalmeterolIn period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.

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
Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
Smoking history of at least 20 pack years
Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

Key exclusion criteria (16 listed)

Pregnant or lactating females
Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients requiring long term oxygen therapy (>15 h a day)
Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis

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
IndacaterolAlso: QAB149300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)	Drug	Indacaterol Evening, Placebo, Salmeterol, Indacaterol Evening,Indacaterol Morning, Placebo, Indacaterol Evening,Salmeterol, Indacaterol Morning, Indacaterol Morning, Placebo, Indacaterol Evening, Indacaterol Morning, Salmeterol, Placebo, Indacaterol Morning,Indacaterol Evening, Salmeterol, Placebo, Indacaterol Evening, Indacaterol Morning, Placebo, Indacaterol Morning, Salmeterol, Placebo, Salmeterol, Indacaterol Evening, Salmeterol, Indacaterol Evening, Placebo, Salmeterol, Indacaterol Morning, Indacaterol Evening, Salmeterol, Placebo, Indacaterol Morning
SalmeterolAlso: Serevent®50 µg twice daily delivered via dry powder inhaler (DPI)	Drug	Indacaterol Evening, Placebo, Salmeterol, Indacaterol Evening,Salmeterol, Indacaterol Morning, Indacaterol Morning, Salmeterol, Placebo, Indacaterol Morning,Indacaterol Evening, Salmeterol, Placebo, Indacaterol Morning, Salmeterol, Placebo, Salmeterol, Indacaterol Evening, Salmeterol, Indacaterol Evening, Placebo, Salmeterol, Indacaterol Morning, Indacaterol Evening, Salmeterol, Placebo, Indacaterol Morning
Placebo to IndacaterolPlacebo matching indacaterol was delivered via SDDPI.	Drug	Indacaterol Evening, Placebo, Salmeterol, Indacaterol Evening,Indacaterol Morning, Placebo, Indacaterol Evening,Salmeterol, Indacaterol Morning, Indacaterol Morning, Placebo, Indacaterol Evening, Indacaterol Morning, Salmeterol, Placebo, Indacaterol Morning,Indacaterol Evening, Salmeterol, Placebo, Indacaterol Evening, Indacaterol Morning, Placebo, Indacaterol Morning, Salmeterol, Placebo, Salmeterol, Indacaterol Evening, Salmeterol, Indacaterol Evening, Placebo, Salmeterol, Indacaterol Morning, Indacaterol Evening, Salmeterol, Placebo, Indacaterol Morning
Placebo to SalmeterolPlacebo matching salmeterol was delivered via DPI	Drug	Indacaterol Evening, Placebo, Salmeterol, Indacaterol Evening,Indacaterol Morning, Placebo, Indacaterol Evening,Salmeterol, Indacaterol Morning, Indacaterol Morning, Placebo, Indacaterol Evening, Indacaterol Morning, Salmeterol, Placebo, Indacaterol Morning,Indacaterol Evening, Salmeterol, Placebo, Indacaterol Evening, Indacaterol Morning, Placebo, Indacaterol Morning, Salmeterol, Placebo, Salmeterol, Indacaterol Evening, Salmeterol, Indacaterol Evening, Placebo, Salmeterol, Indacaterol Morning, Indacaterol Evening, Salmeterol, Placebo, Indacaterol Morning

Primary outcome

Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo
Time frame: After 14 days of treatment
Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 10 min and 23h 45 min post dose. The primary variable was analyzed using an analysis of covariance (ANCOVA) model with the (period) baseline FEV1 as covariate. The (period) baseline FEV1 was defined as the value measured before the study drug administration in that treatment period.

1 secondary outcome

Trough FEV1 Assessed After 14 Days of Dosing for All Other Treatment Comparisons
Time frame: After 14 days of dosing

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
Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol	9	8
Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo	8	8
Sequence 3: Salmeterol, Placebo, Indacaterol Morning	9	9
Sequence 4: Placebo, Salmeterol, Indacaterol Evening	8	8
Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening	9	8
Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning	6	5
Sequence 7: Salmeterol, Indacaterol Evening, Placebo	7	7
Sequence 8: Placebo, Indacaterol Morning, Salmeterol	7	7
Sequence 9:Indacaterol Morning, Salmeterol, Placebo	9	8
Sequence 10: Indacaterol Evening, Placebo, Salmeterol	8	8
Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening	8	7
Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning	7	6

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo

Time frame: After 14 days of treatment. Least squares mean (Standard Error). Unit: Liters

Measure	Indacaterol Evening n = 63	Placebo n = 64
Value	1.57 (0.025)	1.37 (0.025)

Population analysed: The modified intention-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients who received only one treatment were also included for calculation of treatment means. This analysis included all patients who received indacaterol in the evening or placebo in their assigned treatment sequence.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol Evening	0 of 65 (0%)	10 of 65 (15.4%)	Not reported
Indacaterol Morning	1 of 68 (1.5%)	4 of 68 (5.9%)	Not reported
Salmeterol	0 of 68 (0%)	3 of 68 (4.4%)	Not reported
Placebo	0 of 68 (0%)	5 of 68 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20850959Magnussen H, Verkindre C, Jack D, Jadayel D, Henley M, Woessner R, Higgins M, Kramer B; INPUT study investigators. Indacaterol once-daily is equally effective dosed in the evening or morning in COPD. Respir Med. 2010 Dec;104(12):1869-76. doi: 10.1016/j.rmed.2010.08.010. Epub 2010 Sep 20.

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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 principal investigator

+ 41 61 324 1111

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 7 sites in 3 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 16 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 17 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 7 sites in Germany, France, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Trough Forced Expiratory Volume in 1 Second (FEV1) Following 14 Days of Evening Dosing of Indacaterol Versus Placebo (time frame: After 14 days of treatment). 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 NCT00615030, which also lists 1 linked publication.

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 17 Aug 2011.