Chronic Obstructive Pulmonary DiseasePhase 2NCT00531050

Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol

A Phase 2 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 1 site in Belgium.

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 investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Indacaterol and Salmeterol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteBelgium
Study dates: Aug 2007to Jun 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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception.
Body mass index (BMI) must be within the range of 18 to 32.

Who cannot join

Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
Donation or loss of 400 mL or more of blood within two months prior to dosing.
Significant illness (other than respiratory) within two weeks prior to dosing.
A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.
Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis.
History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).

Show all 11Show fewer

A known hypersensitivity to the study drug or drugs similar to the study drug.
History of immunocompromise, including a positive HIV, Hepatitis B or C test result.
History of drug or alcohol abuse within the 12 months prior to dosing
Any conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Novartis Investigative site
Antwerp

Other trials in Belgium

About this study

Official title: A Double-blind, Randomized, Cross-over, Placebo-controlled, 2-part Study to Compare the Effect of Exercise and High-dose Salbutamol on Maximal Heart-rate in Patients With COPD Following Therapeutic Doses of Inhaled QAB149 and Salmeterol

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Indacaterol, Placebo, Salmeterol
Keywords: COPD, cycle ergometry, exercise testing, spirometry, cardiovascular, salbutamol, indacaterol, chronic obstructive pulmonary disease
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
Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).
PlaceboDrug
Single dose indacaterol matching placebo via Concept 1 device
SalmeterolDrug
Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.

Study groups in NCT00531050
Study group	Role	What they receive
Part 1: Sequence A, Part 2: Sequence A	Experimental	Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol
Part 1 : Sequence B, Part 2: Sequence B	Experimental	Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol
Part 1: Sequence C, Part 2: Sequence C	Experimental	Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol
Part 1; Sequence D, Part 2: Sequence D	Experimental	Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol
Part 1: Sequence E, Part 2: Sequence E	Experimental	Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol
Part 1: Sequence F, Part 2: Sequence F	Experimental	Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. Receives: Drug: Indacaterol; Drug: Placebo; Drug: Salmeterol

What is being measured

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

Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study
The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.
Measured: 24-hours post-dose on Day 1 (of each treatment)
Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study
The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined.
- 0-12 hours: post first dose measurements up to second dose
- 12-24 hours: post second dose measurement up to and including the 24 hour measurement
- 0-24 hours: all post dose measurements up to and including the 24 hour measurement
Measured: 24 hours post dose on Day 1
Maximum Heart Rate During Exercise in Part 1
Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.
Measured: 2 hour post-dose on Day 1
Maximum Heart Rate (HR) During Salbutamol Administration in Part 2
Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.
Measured: 24 hours post dose on Day 1

Secondary outcomes (2)

Change in Heart Rate During Exercise in Part 1
Change in heart rate is calculated from the 1.5 hour post dose to the maximum heart rate during exercise.
Analysis of covariance included treatment and period as fixed effects, subject as random effect and 1.5 hour pre-exercise/post dose heart rate as a covariate.
Measured: 1.5 hour post dose to max heart rate during exercise
Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hours 30 minutes and 24 hours post morning dose FEV1 measurements. Analysis of covariance included pre-dose FEV1 as covariate.
Measured: 23 hours 30 minutes and 24 hours post-dose at Day 1

Timeline

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

Aug 2007Jun 2008

First posted18 Sep 2007 (estimated)
Study startAug 2007
Primary completionJun 2008
Study completionJun 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 Chronic Obstructive Pulmonary DiseaseStudies 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00531050
Sponsor's protocol ID: CQAB149B2217
Status last verified: Apr 2012
First submitted: 17 Sep 2007
Last updated: 23 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Cross-over, Placebo-controlled, 2-part Study to Compare the Effect of Exercise and High-dose Salbutamol on Maximal Heart-rate in Patients With COPD Following Therapeutic Doses of Inhaled QAB149 and Salmeterol
ClinicalTrials.gov ID: NCT00531050
Acronym / sponsor ID: CQAB149B2217
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, cycle ergometry, exercise testing, spirometry, cardiovascular, salbutamol, indacaterol, chronic obstructive pulmonary disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 23 May 2012

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, investigator)
Number of arms: 6

Arm	Type	Receives
Part 1: Sequence A, Part 2: Sequence A	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Part 1 : Sequence B, Part 2: Sequence B	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Part 1: Sequence C, Part 2: Sequence C	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Part 1; Sequence D, Part 2: Sequence D	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Part 1: Sequence E, Part 2: Sequence E	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
Part 1: Sequence F, Part 2: Sequence F	Experimental	Drug: Indacaterol, Drug: Placebo, Drug: SalmeterolPart 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception.
Body mass index (BMI) must be within the range of 18 to 32.

Key exclusion criteria (11 listed)

Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
Donation or loss of 400 mL or more of blood within two months prior to dosing.
Significant illness (other than respiratory) within two weeks prior to dosing.
A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.
Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis.

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
IndacaterolSingle dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).	Drug	Part 1 : Sequence B, Part 2: Sequence B, Part 1: Sequence A, Part 2: Sequence A, Part 1: Sequence C, Part 2: Sequence C, Part 1: Sequence E, Part 2: Sequence E, Part 1: Sequence F, Part 2: Sequence F, Part 1; Sequence D, Part 2: Sequence D
PlaceboSingle dose indacaterol matching placebo via Concept 1 device	Drug	Part 1 : Sequence B, Part 2: Sequence B, Part 1: Sequence A, Part 2: Sequence A, Part 1: Sequence C, Part 2: Sequence C, Part 1: Sequence E, Part 2: Sequence E, Part 1: Sequence F, Part 2: Sequence F, Part 1; Sequence D, Part 2: Sequence D
SalmeterolSingle dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.	Drug	Part 1 : Sequence B, Part 2: Sequence B, Part 1: Sequence A, Part 2: Sequence A, Part 1: Sequence C, Part 2: Sequence C, Part 1: Sequence E, Part 2: Sequence E, Part 1: Sequence F, Part 2: Sequence F, Part 1; Sequence D, Part 2: Sequence D

Primary outcome

Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study
Time frame: 24-hours post-dose on Day 1 (of each treatment)
The percentage of patients with an increase of more than 10 beats per minute (bpm) in their heart rate following treatment with indacaterol and salmeterol compared to treatment with placebo was determined.
Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study
Time frame: 24 hours post dose on Day 1
The percentage of patients with an increase of >= 10 beats per minute (bpm) in their heart rate (HR) following treatment with indacaterol and salmeterol compared to treatment with placebo over 24 hours in Part 2 was determined. * 0-12 hours: post first dose measurements up to second dose * 12-24 hours: post second dose measurement up to and including the 24 hour measurement * 0-24 hours: all post dose measurements up to and including the 24 hour measurement
Maximum Heart Rate During Exercise in Part 1
Time frame: 2 hour post-dose on Day 1
Maximum heart rate was generally taken from the continuous ECG monitoring. Analysis based on mixed effects analysis using model with treatment and period as fixed effects and subject as random effect.
Maximum Heart Rate (HR) During Salbutamol Administration in Part 2
Time frame: 24 hours post dose on Day 1
Maximum HR (0-12 hours): maximum (max) of post dose measurement up to second administration. Maximum HR (12-24 hours): max of the post second administration of salbutamol measurements. Maximum HR (0-24 hours): max of all post dose measurements up to and including the 24 hour measurement. Mixed effects analysis model used period baseline HR as the covariate. The maximum HR for 0-24 hours (h) is the maximum of the maximum HR for the two 12h periods and thus the average (LS means) of the maximum HRs for 0-24h will be equal to or greater than the average of the maximum for the two periods.

2 secondary outcomes

Change in Heart Rate During Exercise in Part 1
Time frame: 1.5 hour post dose to max heart rate during exercise
Trough Forced Expiratory Volume in 1 Second (FEV1) During Part 1 and Part 2
Time frame: 23 hours 30 minutes and 24 hours post-dose at Day 1

Results and safety

Results posted to the registry on 23 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Sequence A, Part 2: Sequence A	4	4
Part 1 : Sequence B, Part 2: Sequence B	5	4
Part 1: Sequence C, Part 2: Sequence C	4	4
Part 1; Sequence D, Part 2: Sequence D	5	4
Part 1: Sequence E, Part 2: Sequence E	4	4
Part 1: Sequence F, Part 2: Sequence F	5	5

Primary outcome: Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study

Time frame: 24-hours post-dose on Day 1 (of each treatment). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Part 1: Indacaterol 300μg n = 25	Part 1 : Salmeterol 50μg n = 25
Value	20.00 (6.83 to 40.70)	16.0 (4.54 to 36.0)

Population analysed: The safety population consisted of all subjects who received at least one dose of study medication after randomization.

Primary outcome: Percentage of Participants With Maximum Heart Rate Increase During Salbutamol Administration in Part 2 of the Study

Time frame: 24 hours post dose on Day 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Part 2:Indacaterol 300μg Morning/Placebo Evening n = 23	Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening n = 23
0 - 12 hours (N= 23,23)	17.39 (4.95 to 38.78)	17.39 (4.95 to 38.78)
12 - 24 hours (N= 20, 20)	10.00 (1.23 to 31.70)	25.00 (8.66 to 49.10)
0 - 24 hours (N= 23, 23)	13.04 (2.78 to 33.59)	17.39 (4.95 to 38.78)

Population analysed: Safety population. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate. In a patient where data for the second 12 hour period is missing, 0-24 is not reported; hence the discrepancy of 4 and 3 subjects.

Primary outcome: Maximum Heart Rate During Exercise in Part 1

Time frame: 2 hour post-dose on Day 1. Least squares mean (95% Confidence Interval). Unit: Beats per minute (bpm)

Measure	Part 1: Indacaterol 300μg n = 26	Part 1 : Salmeterol 50μg n = 25	Part 1: Placebo n = 26
Value	133.13 (125.90 to 140.36)	131.18 (123.86 to 138.49)	129.96 (122.73 to 137.19)

Population analysed: The safety population consisted of all subjects who received at least one dose of study medication after randomization.

Primary outcome: Maximum Heart Rate (HR) During Salbutamol Administration in Part 2

Time frame: 24 hours post dose on Day 1. Least squares mean (95% Confidence Interval). Unit: Beats per minute (bpm)

Measure	Part 2:Indacaterol 300μg Morning/Placebo Evening n = 23	Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening n = 24	Part 2:Placebo Morning/Placebo Evening n = 23
0 - 12 hours (N= 23, 24, 23)	98.026 (90.407 to 105.645)	98.087 (90.575 to 105.598)	97.960 (90.317 to 105.603)
12 - 24 hours (N= 20, 21, 20)	97.179 (91.195 to 103.164)	99.954 (94.047 to 105.861)	97.786 (91.779 to 103.794)
0 - 24 hours (N= 23, 24, 23)	102.501 (95.504 to 109.498)	102.303 (95.394 to 109.212)	103.951 (96.931 to 110.971)

Population analysed: The safety population consisted of all subjects who received at least one dose of study medication after randomization. ECG monitoring was not performed successfully for three subjects in Part 2 during the afternoon monitoring. These subjects were therefore excluded from the analysis of heart rate.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1:Indacaterol 300mcg	1 of 26 (3.8%)	9 of 26 (34.6%)	Not reported
Part 1:Salmeterol 50mcg	0 of 25 (0%)	4 of 25 (16%)	Not reported
Part 1:Placebo	1 of 26 (3.8%)	4 of 26 (15.4%)	Not reported
Part 2:Indacaterol 300μg Morning/Placebo Evening	0 of 23 (0%)	8 of 23 (34.8%)	Not reported
Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
Part 2:Placebo Morning/Placebo Evening	0 of 23 (0%)	6 of 23 (26.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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 principal investigator

Investigative site

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 1 site in Belgium.

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 11 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 23 May 2012). 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?

Percentage of Participants With Maximum Heart Rate Increase During Exercise in Part 1 of the Study (time frame: 24-hours post-dose on Day 1 (of each treatment)). The study lists 4 primary outcomes in all. 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 NCT00531050.

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 23 May 2012.