COPDPhase 4NCT00569270

Dynamic Hyperinflation and Tiotropium

A Phase 4 study of COPD, run by Gelb, Arthur F., M.D. at 2 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 40 to 85 years
Conditions the study is for: COPD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 2 sitesin 2 countries
Study dates: Oct 2006to Mar 2009
Phase: Phase 4
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC < 70%.
Smoking history > 10 pack yr.
Clinically stable X 6 weeks.
No oxygen usage.

Who cannot join

History of asthma
Clinically unstable
Any other significant medical problem precluding full cooperation for study

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Arthur F Gelb MD
Lakewood, California, 90712

Other trials in United States

Canada1 site

Noe Zamel MD
Toronto, Ontario

Other trials in Canada

About this study

Official title: Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD

We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease) patients with moderately severe disease using metronome paced hyperventilation (MPH) with inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized crossover double blinded study.

Read the detailed description

Study completed with 29 patients studied. Data is being analyzed to evaluate trough and peak effect of 18 µg tiotropium vs placebo on FEV 1 (L)(forced expiratory capacity in one second), inspiratory capacity and functional residual volume. In addition, we will study the effect of 18 µg tiotropium vs placebo on metronome paced hyperventilation induced dynamic hyperinflation. We will also evaluate the effect of tiotropium induced increase in IC (inspiratory capacity) vs extent of emphysema as evaluated on high resolution thin section CT lung

Conditions: COPD
Being tested: Placebo
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.

PlaceboDrug
Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation

Study groups in NCT00569270
Study group	Role	What they receive
Tiotropium 18 µg capsule, bronchodilator	Active comparator	tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo Receives: Drug: Placebo
2	Placebo comparator	placebo 18ug tiotropium for 1 month Receives: Drug: Placebo

What is being measured

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

Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-
Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second
Measured: 30 days
Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)
Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.
Measured: 30 days
Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo
Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters
Measured: 30 days
Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo
Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters
Measured: 30 days
Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo
Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage
Measured: 30 days
Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo
Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters
Measured: 30 days
Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo
Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)
Measured: 30 days
Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo
Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)
Measured: 30 days
Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo
Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients
Measured: 30 days
Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo
Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters
Measured: 30 days
Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo
Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage
Measured: 30 days
Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo
Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients
Measured: 30 days
IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline
IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo
Measured: baseline and 30 days (+2h) post dose
TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo
Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention \& 2 hrs. after after 30 days of treatment with either placebo or tiotropium
Measured: one hour before intervention & 2 hrs. after after 30 days

Secondary outcomes (3)

Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium
Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to FEV 1; correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measures include increase in FEV1 from baseline to peak tiotropium
Measured: baseline to 30 days
IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema
Correlation between change in inspiratory capacity (L) post metronome paced hyperventilation induced dynamic hyperinflation and extent of lung ct scored emphysema
Measured: baseline to 30 days
Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium
Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema
Measured: baseline to trough tiotropium

Timeline

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

Oct 2006Mar 2009

First posted7 Dec 2007 (estimated)
Study startOct 2006
Primary completionFeb 2009
Study completionMar 2009

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 (3)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00569270
Sponsor's protocol ID: 20061693
Other IDs: IIS Boehringer-Ingelheim, IIS Pfizer
Status last verified: Jul 2017
First submitted: 6 Dec 2007
Last updated: 20 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: Please see published data

Publications

Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60. doi: 10.1378/chest.126.6.1855.
PubMed 15596684
Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-695. doi: 10.1378/chest.06-1662.
PubMed 17356081
Gelb AF, Fraser C, Zamel N. Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPD. Respir Med. 2011 May;105(5):755-60. doi: 10.1016/j.rmed.2010.11.020. Epub 2010 Dec 14.
PubMed 21159499

Want to know more?

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

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

Questions to ask the study team

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

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simplified Detection of Dynamic Hyperinflation Using Metronome Paced Hyperventilation and the Effect of Tiotropium in Patients With COPD
ClinicalTrials.gov ID: NCT00569270
Acronym / sponsor ID: 20061693
Conditions: COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Gelb, Arthur F., M.D.
Collaborators: Boehringer Ingelheim, Pfizer
Study start: Oct 2006
Primary completion: Feb 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 7 Dec 2007 (estimated)
Results: Posted 5 Oct 2012

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tiotropium 18 µg capsule, bronchodilator	Active comparator	Drug: Placebotiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
2	Placebo comparator	Drug: Placeboplacebo 18ug tiotropium for 1 month

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC < 70%.
Smoking history > 10 pack yr.
Clinically stable X 6 weeks.
No oxygen usage.

Key exclusion criteria (3 listed)

History of asthma
Clinically unstable
Any other significant medical problem precluding full cooperation for study

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

Interventions

Intervention	Type	Arms
PlaceboProcedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation	Drug	2, Tiotropium 18 µg capsule, bronchodilator

Primary outcome

Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-
Time frame: 30 days
Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second
Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)
Time frame: 30 days
Lung function studies (mean +/- SD): peak FRC after 30 days (+2h) of placebo or tiotropium in 29 moderate COPD patients.
Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo
Time frame: 30 days
Lung function studies (mean +/- SD) of peak forced vital capaciy (L) after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients. Forced vital capacity - liters
Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies (mean +/- SD) - Peak inspiratory capacity after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Inspiratory capacity- liters
Bronchodilator Response: Peak FRC/TLC Percentage (Functional Residual Capacity(L)/Total Lung Capacity(L) - Tiotropium or Placebo
Time frame: 30 days
Lung function studies (mean +/- SD) peak Peak FRC/TLC after 30 days (+2h)of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity/total lung capacity - percentage
Bronchodilator Response: Peak TLC (L) (Total Lung Capacity)- Tiotropium or Placebo
Time frame: 30 days
Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients. Total lung capacity - liters
Bronchodilator Response: Trough FEV1 (L)- (Forced Expiratory Volume) Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies Trough FEV1(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Forced expiratory volume in 1s (liters)
Bronchodilator Response: Trough FRC (L)- Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies Trough FRC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients. Functional residual capacity(liters)
Bronchodilator Response: Trough FVC (L)- (Forced Vital Capacity) Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies Trough FVC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients
Bronchodilator Response: Trough IC (L) Inspiratory Capacity - Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies (Trough IC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough inspiratory capacity- liters
Bronchodilator Response: Trough FRC/TLC (Functional Residual Capacity/Total Lung Capacity)- Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies Trough FRC/TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients Trough Functional residual capacity/total lung capacity - percentage
Bronchodilator Response: Trough TLC (L) (Total Lung Capacity)- Tiotropium Versus Placebo
Time frame: 30 days
Lung function studies Trough TLC(mean +/- SD) after 30 days(-1h) of tiotropium versus placebo in 29 moderate COPD patients
IC (Inspiratory Capacity L)and Metronome Paced Hyperventilation-induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo and Baseline
Time frame: baseline and 30 days (+2h) post dose
IC measurement before and after metronome paced hyperventilation-induced dynamic hyperinflation at baseline and in tiotropium and placebo groups. Measure ratio of functional residual capacity divided by total lung capacity at baseline and after 30 days of tiotropium versus placebo
TLC (L) Before and After Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in Tiotropium Cohort Versus Placebo
Time frame: one hour before intervention & 2 hrs. after after 30 days
Total lung capacity before and after metronome paced hyperventilation induced dynamic hyperinflation in tiotropium cohort versus placebo. Difference between TLC measured at one hour before intervention \& 2 hrs. after after 30 days of treatment with either placebo or tiotropium

3 secondary outcomes

Extent of Lung CT Scored Emphysema and and Lung Function of FEV1(l) After Tiotropium
Time frame: baseline to 30 days
IC (Inspiratory Capacity, L) Post Mph (Metronome Paced Hyperventilation) Induced dh (Dynamic Hyperinflation) After Tiotropium and Extent of Lung CT Scored Emphysema
Time frame: baseline to 30 days
Extent of Lung CT Scored Emphysema and and Lung Function of FRC/TLC (Functional Residual Capacity(L)/Total Lung Capacity (L) After Tiotropium
Time frame: baseline to trough tiotropium

Results and safety

Results posted to the registry on 5 Oct 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 18 µg Capsule First, Then Placebo	15	15
Placebo First, Then Tiotropium Bromide 18 µg	15	14

Primary outcome: Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)-

Time frame: 30 days. Mean (Standard Deviation). Unit: liters

Measure	Placebo n = 29	Tiotropium n = 29
Value	1.74 (0.58)	1.82 (0.59)

Placebo vs Tiotropium: p = 0.027, Mixed Models Analysis

Population analysed: Lung function studies (mean +/- SD): peak FEV1 (+2h) after 30 days of placebo or tiotropium in 29 moderate COPD patients. FEV1 = Forced expiratory volume in one second

Primary outcome: Bronchodilator Response:Peak FRC (L) (Functional Residual Capacity)

Time frame: 30 days. Mean (Standard Deviation). Unit: Liters

Measure	Placebo n = 29	Tiotropium n = 29
Value	3.80 (0.79)	3.72 (0.84)

Placebo vs Tiotropium: p = 0.318, Mixed Models Analysis

Population analysed: Includes groups randomized to receive placebo first and Tiotropium first.

Primary outcome: Bronchodilator Response: Peak FVC (L) (Forced Vital Capacity)- Tiotropium and Placebo

Time frame: 30 days. Mean (Standard Deviation). Unit: liters

Measure	Placebo n = 29	Tiotropium 18 µg Capsule, Bronchodilator n = 29
Value	3.17 (1.13)	3.27 (1.16)

Placebo: p = 0.078, Mixed Models Analysis

Population analysed: Peak FVC after 30 days (+2h) of tiotropium versus placebo in 29 moderate COPD patients.

Primary outcome: Bronchodilator Response: Peak IC (L) - (Inspiratory Capacity) - Tiotropium Versus Placebo

Time frame: 30 days. Mean (Standard Deviation). Unit: liters

Measure	Placebo n = 29	Tiotropium n = 29
Value	2.12 (0.82)	2.24 (0.80)

Placebo vs Tiotropium: p = 0.067, Mixed Models Analysis

Population analysed: Net change in lung function studies (mean +/- SE) from baseline to trough (-1h) and peak (+2h) after 30 days of tiotropium versus placebo in 29 moderate COPD patients.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tiotropium Bromide 18 µg, Capsule,	0 of 30 (0%)	0 of 30 (0%)	Not reported
Placebo	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15596684Gelb AF, Gutierrez CA, Weisman IM, Newsom R, Taylor CF, Zamel N. Simplified detection of dynamic hyperinflation. Chest. 2004 Dec;126(6):1855-60. doi: 10.1378/chest.126.6.1855.
Background: PubMed 17356081Gelb AF, Taylor CF, McClean PA, Shinar CM, Rodrigues MT, Gutierrez CA, Chapman KR, Zamel N. Tiotropium and simplified detection of dynamic hyperinflation. Chest. 2007 Mar;131(3):690-695. doi: 10.1378/chest.06-1662.
Derived from this study: PubMed 21159499Gelb AF, Fraser C, Zamel N. Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPD. Respir Med. 2011 May;105(5):755-60. doi: 10.1016/j.rmed.2010.11.020. Epub 2010 Dec 14.
Individual participant dataSharing planned: No. Please see published data

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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.

Arthur F Gelb, MD principal investigator

Arthur F Gelb Medical Corporation

Noe Zamel, MD principal investigator

Mt. Sinai Hosp. Toronto, Univ Toronto Medical Center

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study of COPD, run by Gelb, Arthur F., M.D. at 2 sites in 2 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 4 inclusion and 3 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Oct 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?

Bronchodilator Response:Peak FEV1(L)(Forced Expiratory Volume in One Second)- (time frame: 30 days). The study lists 14 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 NCT00569270, which also lists 3 linked publications.

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 20 Aug 2019.