Lung DiseasesNCT02024204

Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program

A study testing Fluticasone propionate 230mcg for 3 Months, Current Treatment or no treatment and Salmeterol 21mcg for 3 Months in people with Lung Diseases and Medication Compliance, run by NYU Langone Health at 1 site in United States.

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 18 to 75 years
Conditions the study is for: Lung Diseases, Medication Compliance
What is being tested?: Fluticasone propionate 230mcg for 3 Months, Current Treatment or no treatment and Salmeterol 21mcg for 3 Months
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 9 Apr 2014to 17 May 2017
Phase: Interventional
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years and <75
Meet criteria for World Trade Center Environmental Health Center enrollment
Onset of lower respiratory symptoms after 9/11/01
Persistent lower respiratory symptoms (> 2 times per week)
Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits
< 5 pack-year tobacco history

Show all 9Show fewer

Not current smoker
Asthma Control Test Score ≤ 19
Normal chest x-ray

Who cannot join

Age < 18 years and ≥75
Lower respiratory symptoms or asthma history pre 9/11/01
No persistent lower respiratory symptoms
pre-bronchodilator FEV1 within normal limits
> 5 pack year tobacco
Current smoker

Show all 14Show fewer

Abnormal Chest X-Ray or parenchymal changes on high resolution computed tomography
Uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer)
History of significant non-World Trade Center occupational or environmental exposure
Allergy to study drug
Pregnancy, lactation or plans to become pregnant
Chronic oral corticosteroid use
High risk of fatal or near-fatal asthma within the previous 2 years
Other lung disease (Idiopathic pulmonary fibrosis,sarcoid, etc.)

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program

The purpose of this study is to understand why patients in the World Trade Center program have continuing breathing problems. This study will improve investigators understanding of breathing problems among individuals with World Trade Center exposure by allowing them to review and monitor medication use, lung function, and examine other conditions that can contribute to problems with breathing. The findings from the study will help investigators understand why some people have persistent lower respiratory symptoms (breathing problems) after their exposure to World Trade Center dust and fumes, and may help guide better management and treatment of these symptoms.

Read the detailed description

Investigators will conduct a clinical study with aggressive treatment for lower respiratory symptoms in patients in the World Trade Center Environmental Health Center. Patients in the WTC EHC with uncontrolled LRS at visit 1 will be identified and placed on high-dose inhaled corticosteroids and long-acting beta agonists for three months. Adherence will be assessed at monthly visits. Patients will perform spirometry and oscillometry at baseline and after 3 months of treatment. They will also be assessed for markers of airway inflammation, bronchial hyperresponsiveness and co-morbid conditions including depression,anxiety,post-traumatic stress disorder, gastroesophageal reflux, paradoxical vocal cord motion and rhinosinusitis.

Conditions: Lung Diseases, Medication Compliance
Being tested: Fluticasone propionate 230mcg for 3 Months, Current Treatment or no treatment, Salmeterol 21mcg for 3 Months
Keywords: World Trade Center Disaster, Environmental Exposure, Respiratory Physiology, Inflammation, Gastrointestinal Diseases, Sinus Symptoms, PTSD, Anxiety, Depression, Hypersensitivity, Spirometry, Oscillometry
Medical subject headings: Lung Diseases, Medication Adherence, Inflammation, Gastrointestinal Diseases, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Hypersensitivity

What participants receive

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

Fluticasone propionate 230mcg for 3 MonthsDrug
Also called Advair HFA
Current Treatment or no treatmentDrug
Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Salmeterol 21mcg for 3 MonthsDrug

Study groups in NCT02024204
Study group	Role	What they receive
Uncontrolled LRS	Active comparator	Patients who have uncontrolled lower respiratory symptoms (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy. Receives: Drug: Fluticasone propionate 230mcg for 3 Months; Drug: Salmeterol 21mcg for 3 Months
Controlled LRS	Other	Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications. Receives: Drug: Current Treatment or no treatment

What is being measured

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

Forced Oscillation Technique (FOT) Measures
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Measured: Week 12
Spirometry Measures
Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters).
FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity
Measured: Week 12

Secondary outcomes (8)

Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
To test whether bronchial Hyperreactivity (BHR), assessed by methacholine challenge, is associated with uncontrolled lower respiratory symptoms.
Measured: Week 12
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
measured by laryngoscopic visualization at rest or after provocation with various odors or exercise.
Measured: Week 12
Total IgE (Immunoglobulin E) Levels
IgE levels were obtained by blood test - the total amount of blood drawn is 30 mL.
Measured: Week 1
Total EoS (Eosinophil) Counts
EoS counts were obtained by blood test - the total amount of blood drawn is 30 mL.
Measured: Week 1
Levels of Fractional Exhaled Nitric Oxide (FeNO)
Measured using a portable device that measures the level of nitric oxide in parts per billion (PPB) in the air slowly exhaled out of the patient's lungs.
Measured: Week 12
Score on Voice Handicap Index 10 (VHI-10)
Voice Handicap Index 10 is a measure of laryngeal dysfunction or hypersensitivity to capture the "overall" state of voice handicap. The normative value for this instrument is 2.83, with a score > 11 considered abnormal. There are 10 statements that are scored between 0 and 4 (0= never, 4= always). The total range is 0-40, where 40 is highest level of dysfunction.
Measured: Week 12
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
For rhinosinusitis symptoms, the ICSD scoring system was used, with a likert scale of 1-10 for each symptom (total range of scale = 1-60, with higher scores reflecting more symptoms).
Measured: Week 12
Score on Leicester Cough Questionnaire (LCQ)
For rhinosinusitis symptoms, the Leicester Cough Questionnaire (LCQ) was used - a cough-specific health status questionnaire that assesses the physical, psychological, and social domains of cough. The LCQ is made up of 19 items; the total score range is 3-21; a higher score is associated with better health.
Measured: Week 12

Timeline

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

9 Apr 201417 May 2017

First posted31 Dec 2013 (estimated)
Study start9 Apr 2014
Primary completion17 May 2017
Study completion17 May 2017

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 Lung DiseasesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02024204
Sponsor's protocol ID: 13-00448
Other IDs: 1U01OH010404-01A1
Status last verified: Jan 2021
First submitted: 18 Dec 2013
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880
Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b.
PubMed 19365288
Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC.
PubMed 21642248

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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Uncontrolled Lower Respiratory Symptoms in the World Trade Center Survivor Program
ClinicalTrials.gov ID: NCT02024204
Acronym / sponsor ID: 13-00448
Conditions: Lung Diseases, Medication Compliance
Keywords: World Trade Center Disaster, Environmental Exposure, Respiratory Physiology, Inflammation, Gastrointestinal Diseases, Sinus Symptoms, PTSD, Anxiety
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC)
Study start: 9 Apr 2014 (actual)
Primary completion: 17 May 2017 (actual)
Study completion: 17 May 2017 (actual)
First posted: 31 Dec 2013 (estimated)
Results: Posted 2 Feb 2021

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Uncontrolled LRS	Active comparator	Drug: Fluticasone propionate 230mcg for 3 Months, Drug: Salmeterol 21mcg for 3 MonthsPatients who have uncontrolled lower respiratory symptoms (ACT < 20) at time of Visit 1 will be provided with study Advair (Fluticasone propionate 230mcg/salmeterol 21mcg) for a total of 3 months and receive medication adherence counseling Patients who have uncontrolled LRS at V1, but do not fit criteria for Step 3,4 or 5 asthma therapy according to NIH EPR III asthma guidelines will be deferred from the study until they have been seen by their physician and tried on ICS therapy.
Controlled LRS	Other	Drug: Current Treatment or no treatmentPatients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥18 years and <75
Meet criteria for World Trade Center Environmental Health Center enrollment
Onset of lower respiratory symptoms after 9/11/01
Persistent lower respiratory symptoms (> 2 times per week)
Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits

Key exclusion criteria (14 listed)

Age < 18 years and ≥75
Lower respiratory symptoms or asthma history pre 9/11/01
No persistent lower respiratory symptoms
pre-bronchodilator FEV1 within normal limits
> 5 pack year tobacco

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
Fluticasone propionate 230mcg for 3 MonthsAlso: Advair HFA	Drug	Uncontrolled LRS
Current Treatment or no treatmentPatients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.	Drug	Controlled LRS
Salmeterol 21mcg for 3 Months	Drug	Uncontrolled LRS

Primary outcome

Forced Oscillation Technique (FOT) Measures
Time frame: Week 12
Small airway function measured pre/post BD (bronchodilator) impulse oscillometry at resistance 5 Hz (R5) and 5-20 Hz (R5-20).
Spirometry Measures
Time frame: Week 12
Measured pre/post BD (bronchodilator). Reported as ratio: %FEV1(Liters)/FVC(Liters). FEV1 = forced expiratory volume at 1 second FVC = forced vital capacity

8 secondary outcomes

Number of Participants With Positive Level of Bronchial Hyperreactivity (BHR)
Time frame: Week 12
Number of Participants With Positive Level of Paradoxical Vocal Fold Movement (PVFM)
Time frame: Week 12
Total IgE (Immunoglobulin E) Levels
Time frame: Week 1
Total EoS (Eosinophil) Counts
Time frame: Week 1
Levels of Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Week 12
Score on Voice Handicap Index 10 (VHI-10)
Time frame: Week 12
Rhinosinusitis Score on International Classification of Sleep Disorders (ICSD)
Time frame: Week 12
Score on Leicester Cough Questionnaire (LCQ)
Time frame: Week 12

Results and safety

Results posted to the registry on 2 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Visit 1 Uncontrolled LRS	49	49
Visit 1 Controlled LRS	11	11

Primary outcome: Forced Oscillation Technique (FOT) Measures

Time frame: Week 12. Median (Inter-Quartile Range). Unit: resonant frequency

Measure	Visit 1 Uncontrolled LRS n = 49	Visit 1 Controlled LRS n = 11
Pre BD R5	4.4 (3.4 to 5.7)	3.7 (3.3 to 5.7)
Pre BD R5-20	1.0 (0.5 to 1.5)	0.6 (0.4 to 1.4)
Post BD R5	4.1 (3.5 to 5.3)	4.0 (3.4 to 5.7)
Post BD R5-20	0.8 (0.4 to 1.2)	0.6 (0.4 to 1.1)

Primary outcome: Spirometry Measures

Time frame: Week 12. Median (Inter-Quartile Range). Unit: % FEV1(Liters)/FVC(Liters)

Measure	Visit 1 Uncontrolled LRS n = 49	Visit 1 Controlled LRS n = 11
Pre-BD FEV1/FVC	78.5 (72.4 to 82.4)	81.2 (75.3 to 83.4)
Post-BD FEV1/FVC	78.3 (75 to 82.2)	77.7 (75.4 to 81.1)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uncontrolled LRS	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Controlled LRS	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
Background: PubMed 19365288Reibman J, Liu M, Cheng Q, Liautaud S, Rogers L, Lau S, Berger KI, Goldring RM, Marmor M, Fernandez-Beros ME, Tonorezos ES, Caplan-Shaw CE, Gonzalez J, Filner J, Walter D, Kyng K, Rom WN. Characteristics of a residential and working community with diverse exposure to World Trade Center dust, gas, and fumes. J Occup Environ Med. 2009 May;51(5):534-41. doi: 10.1097/JOM.0b013e3181a0365b.
Background: PubMed 21642248Friedman SM, Maslow CB, Reibman J, Pillai PS, Goldring RM, Farfel MR, Stellman SD, Berger KI. Case-control study of lung function in World Trade Center Health Registry area residents and workers. Am J Respir Crit Care Med. 2011 Sep 1;184(5):582-9. doi: 10.1164/rccm.201011-1909OC.

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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.

Joan Reibman, M.D principal investigator

NYU School of Medicine

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

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 14 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 2 Feb 2021. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). 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?

Forced Oscillation Technique (FOT) Measures (time frame: Week 12). The study lists 2 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 NCT02024204, 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 2 Feb 2021.