Chronic Obstructive Pulmonary DiseasePhase 3NCT01012765

Effect of Indacaterol on Inspiratory Capacity (IC)

A Phase 3 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 21 sites in Germany.

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 is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Indacaterol and Tiotropium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 173 participants
Where: 21 sitesGermany
Study dates: Nov 2009to Jan 2011
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

Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).

Who cannot join

Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Germany21 sites

Novartis Investigative Site
Aschaffenburg
Novartis Investigative Site
Berlin
Novartis Investigative Site
Dresden
Novartis Investigative Site
Erfurt
Novartis Investigative site
Frankfurt am Main
Novartis Investigative Site
Fulda
Novartis Investigative Site
Geesthacht
Novartis Investigative Site
Großhansdorf
Novartis Investigative Site
Halle
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Kiel
Novartis Investigative Site
Koblenz
Novartis Investigative site
Leipzig
Novartis Investigative Site
Mannheim
Novartis Investigative Site
Marburg
Novartis Investigative Site
Neumünster
Novartis Investigative Site
Potsdam
Novartis Investigative Site
Rathenow
Novartis Investigative Site
Rüdersdorf
Novartis Investigator Site
Witten
Novartis Investigative Site
Zerbst

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Indacaterol, Tiotropium, Placebo
Keywords: COPD, indacaterol, QAB149, inspiratory capacity
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

IndacaterolDrug
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
TiotropiumDrug
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
PlaceboDrug
Placebo to indacaterol o.d. delivered via SDDPI

Study groups in NCT01012765
Study group	Role	What they receive
Indacaterol - placebo - tiotropium	Experimental	In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Placebo - Tiotropium - Indacaterol	Experimental	In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Tiotropium - indacaterol - placebo	Experimental	In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Placebo - indacaterol - tiotropium	Experimental	In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Indacaterol - tiotropium - placebo	Experimental	In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo
Tiotropium - placebo - indacaterol	Experimental	In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. Receives: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo

What is being measured

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

Peak Inspiratory Capacity (IC) After 21 Days of Treatment
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days

Secondary outcomes (7)

Trough IC After 20 Days of Treatment
Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 20 days
Peak Residual Volume (RV) After 21 Days of Treatment
Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days
FEV1 30 Minutes Post-dose After 21 Days of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 21 days
Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
Measured: 20 days

Timeline

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

Nov 2009Jan 2011

First posted13 Nov 2009 (estimated)
Study startNov 2009
Primary completionJan 2011

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 DiseaseStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01012765
Sponsor's protocol ID: CQAB149BDE01
Other IDs: EUDRACT No.: 2009-013686-26
Status last verified: Feb 2016
First submitted: 11 Nov 2009
Last updated: 17 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Watz H, Krippner F, Kirsten A, Magnussen H, Vogelmeier C. Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease--a randomized, multicenter, double-blind, placebo-controlled study. BMC Pulm Med. 2014 Oct 4;14:158. doi: 10.1186/1471-2466-14-158.
PubMed 25280934

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 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
ClinicalTrials.gov ID: NCT01012765
Acronym / sponsor ID: CQAB149BDE01
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, indacaterol, QAB149, inspiratory capacity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jan 2011 (actual)
First posted: 13 Nov 2009 (estimated)
Results: Posted 17 Feb 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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Indacaterol - placebo - tiotropium	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Placebo - Tiotropium - Indacaterol	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Tiotropium - indacaterol - placebo	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Placebo - indacaterol - tiotropium	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Indacaterol - tiotropium - placebo	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
Tiotropium - placebo - indacaterol	Experimental	Drug: Indacaterol, Drug: Tiotropium, Drug: PlaceboIn treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.

Who may qualify

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

Key inclusion criteria (4 listed)

Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:

Key exclusion criteria (2 listed)

Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply

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

Interventions

Intervention	Type	Arms
IndacaterolIndacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)	Drug	Indacaterol - placebo - tiotropium, Indacaterol - tiotropium - placebo, Placebo - Tiotropium - Indacaterol, Placebo - indacaterol - tiotropium, Tiotropium - indacaterol - placebo, Tiotropium - placebo - indacaterol
TiotropiumTiotropium 18µg o.d. delivered via a proprietary inhalation device.	Drug	Indacaterol - placebo - tiotropium, Indacaterol - tiotropium - placebo, Placebo - Tiotropium - Indacaterol, Placebo - indacaterol - tiotropium, Tiotropium - indacaterol - placebo, Tiotropium - placebo - indacaterol
PlaceboPlacebo to indacaterol o.d. delivered via SDDPI	Drug	Indacaterol - placebo - tiotropium, Indacaterol - tiotropium - placebo, Placebo - Tiotropium - Indacaterol, Placebo - indacaterol - tiotropium, Tiotropium - indacaterol - placebo, Tiotropium - placebo - indacaterol

Primary outcome

Peak Inspiratory Capacity (IC) After 21 Days of Treatment
Time frame: 21 days
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.

7 secondary outcomes

Trough IC After 20 Days of Treatment
Time frame: 20 days
Peak Residual Volume (RV) After 21 Days of Treatment
Time frame: 21 days
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
Time frame: 21 days
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
Time frame: 21 days
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
Time frame: 21 days
FEV1 30 Minutes Post-dose After 21 Days of Treatment
Time frame: 21 days
Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
Time frame: 20 days

Results and safety

Results posted to the registry on 17 Feb 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
Tiotropium - Placebo - Indacaterol	20	17
Indacaterol - Placebo - Tiotropium	21	21
Indacaterol - Tiotropium - Placebo	23	21
Placebo - Indacaterol - Tiotropium	18	15
Placebo - Tiotropium - Indacaterol	22	19
Tiotropium - Indacaterol - Placebo	25	25

Primary outcome: Peak Inspiratory Capacity (IC) After 21 Days of Treatment

Time frame: 21 days. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Indacaterol n = 110	Placebo n = 106	Tiotropium n = 105
Value	2.69 (2.64 to 2.75)	2.48 (2.42 to 2.53)	2.63 (2.58 to 2.69)

Population analysed: Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indacaterol 150ug	1 of 118 (0.8%)	20 of 118 (16.9%)	Not reported
Placebo	1 of 120 (0.8%)	16 of 120 (13.3%)	Not reported
Tiotropium 18ug	3 of 119 (2.5%)	10 of 119 (8.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25280934Watz H, Krippner F, Kirsten A, Magnussen H, Vogelmeier C. Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease--a randomized, multicenter, double-blind, placebo-controlled study. BMC Pulm Med. 2014 Oct 4;14:158. doi: 10.1186/1471-2466-14-158.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 21 sites in Germany.

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 4 inclusion and 2 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. 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 Feb 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?

Peak Inspiratory Capacity (IC) After 21 Days of Treatment (time frame: 21 days). 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 NCT01012765, 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 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.