Pulmonary Disease, Chronic ObstructivePhase 2NCT01033487

A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

A Phase 2 study testing active comparator, Low Dose PF-03635659 and Mid Dose PF-03635659 in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, run by Pfizer at 1 site 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

PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases
What is being tested?: active comparator, Low Dose PF-03635659 and Mid Dose PF-03635659
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteGermany
Study dates: Jan 2010to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Who cannot join

Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Pfizer Investigational Site
Berlin, 10117

Other trials in Germany

About this study

Official title: A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.

Conditions: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Obstructive Airway Disease, COPD
Being tested: placebo, active comparator, Low Dose PF-03635659, Mid Dose PF-03635659, High Dose PF-03635659
Keywords: Safety, Pharmacokinetics, Pharmacodynamics, PF-03635659, COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases

What participants receive

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

placeboDrug
oral inhaled formulation, single dose
active comparatorDrug
oral inhaled formulation, single dose
Low Dose PF-03635659Drug
oral inhaled formulation, single dose, low dose
Mid Dose PF-03635659Drug
oral inhaled formulation, single dose, mid dose
High Dose PF-03635659Drug
oral inhaled formulation, single dose, high dose

Study groups in NCT01033487
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: placebo
active comparator	Active comparator	Not described Receives: Drug: active comparator
PF-03635659	Experimental	Not described Receives: Drug: Low Dose PF-03635659; Drug: Mid Dose PF-03635659; Drug: High Dose PF-03635659

What is being measured

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

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
Measured: Baseline, 24, 24.5 hrs post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Dose Normalized Maximum Observed Plasma Concentration
Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose

Secondary outcomes (4)

Peak Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Measured: Baseline up to 48 hrs post-dose
Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
Measured: Baseline up to 24.5 hrs post-dose
Change From Baseline in Force Vital Capacity (FVC)
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
Change From Baseline in Inspiratory Capacity (IC)
IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.
Measured: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose

Timeline

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

Jan 2010Jun 2010

First posted16 Dec 2009 (estimated)
Study startJan 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01033487
Sponsor's protocol ID: B0431010
Status last verified: Jan 2016
First submitted: 15 Dec 2009
Last updated: 19 Feb 2016
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?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
ClinicalTrials.gov ID: NCT01033487
Acronym / sponsor ID: B0431010
Conditions: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Tract Diseases, Chronic Obstructive Airway Disease, COPD
Keywords: Safety, Pharmacokinetics, Pharmacodynamics, PF-03635659, COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 16 Dec 2009 (estimated)
Results: Posted 19 Feb 2016

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: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placebo
active comparator	Active comparator	Drug: active comparator
PF-03635659	Experimental	Drug: Low Dose PF-03635659, Drug: Mid Dose PF-03635659, Drug: High Dose PF-03635659

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Key exclusion criteria (2 listed)

Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

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
placebooral inhaled formulation, single dose	Drug	Placebo
active comparatororal inhaled formulation, single dose	Drug	active comparator
Low Dose PF-03635659oral inhaled formulation, single dose, low dose	Drug	PF-03635659
Mid Dose PF-03635659oral inhaled formulation, single dose, mid dose	Drug	PF-03635659
High Dose PF-03635659oral inhaled formulation, single dose, high dose	Drug	PF-03635659

Primary outcome

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, 24, 24.5 hrs post-dose
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
Maximum Observed Plasma Concentration (Cmax)
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Dose Normalized Maximum Observed Plasma Concentration
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).
Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
Plasma Decay Half-Life (t1/2)
Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

4 secondary outcomes

Peak Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline up to 48 hrs post-dose
Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
Time frame: Baseline up to 24.5 hrs post-dose
Change From Baseline in Force Vital Capacity (FVC)
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
Change From Baseline in Inspiratory Capacity (IC)
Time frame: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose

Results and safety

Results posted to the registry on 19 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450	2	2
PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18	3	3
PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO	2	2
PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180	2	2
Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580	2	2
PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO	2	2
Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180	2	2
PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580	3	3
PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450	2	2
PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18	2	2

Primary outcome: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)

Time frame: Baseline, 24, 24.5 hrs post-dose. Mean (Standard Deviation). Unit: Liter

Measure	PF-03635659 180 mcg n = 22	PF-03635659 580 mcg n = 22	PF-03635659 1450 mcg n = 21	Spiriva (Tiotropium) 18 mcg n = 22	Placebo n = 22
Baseline	1.61 (0.409)	1.58 (0.407)	1.62 (0.393)	1.62 (0.426)	1.67 (0.427)
Change in Trough FEV1	0.147 (0.1802)	0.167 (0.1456)	0.188 (0.1794)	0.115 (0.1734)	0.038 (0.1486)

PF-03635659 180 mcg vs Placebo: Mean Difference (Final Values): 0.0507, Emax Model
PF-03635659 580 mcg vs Placebo: Mean Difference (Final Values): 0.0788, Emax Model
PF-03635659 1450 mcg vs Placebo: Mean Difference (Final Values): 0.0927, Emax Model

Population analysed: Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose. Geometric mean (Standard Deviation). Unit: Picogram/milliliter (pg/mL)

Measure	PF-03635659 180 mcg n = 22	PF-03635659 580 mcg n = 22	PF-03635659 1450 mcg n = 21
Value	53.21 (40.163)	169.4 (61.112)	471.2 (202.73)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.

Primary outcome: Dose Normalized Maximum Observed Plasma Concentration

Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose. Geometric mean (Standard Deviation). Unit: (pg/mL)/mcg

Measure	PF-03635659 180 mcg n = 22	PF-03635659 580 mcg n = 22	PF-03635659 1450 mcg n = 21
Value	1.331 (1.0046)	1.323 (0.4766)	1.474 (0.6327)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose. Median (Full Range). Unit: hr

Measure	PF-03635659 180 mcg n = 15	PF-03635659 580 mcg n = 22	PF-03635659 1450 mcg n = 21
Value	0.533 (0.433 to 1.93)	0.950 (0.433 to 3.95)	0.467 (0.417 to 1.95)

Population analysed: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-03635659 180 mcg	0 of 22 (0%)	2 of 22 (9.1%)	Not reported
PF-03635659 580 mcg	0 of 22 (0%)	3 of 22 (13.6%)	Not reported
PF-03635659 1450 mcg	0 of 21 (0%)	1 of 21 (4.8%)	Not reported
Spiriva (Tiotropium) 18 mcg	1 of 22 (4.5%)	6 of 22 (27.3%)	Not reported
Placebo	0 of 22 (0%)	4 of 22 (18.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 active comparator, Low Dose PF-03635659 and Mid Dose PF-03635659 in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, run by Pfizer at 1 site 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 3 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 19 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 1 site 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. 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 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 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline, 24, 24.5 hrs post-dose). The study lists 9 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 NCT01033487.

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 19 Feb 2016.