COPDPhase 4NCT04520230

Three Treatment of Chronic Obstructive Pulmonary Disease Patients

A Phase 4 study testing Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid, Tiotropium 18 mcg capsule inhaled once daily + Budesonide and Formoterol/Tiotropium in people with COPD, run by Tanta University.

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

Forty five COPD patients will be recruited from Chest Disease Department, Tanta University Hospital, Tanta, Egypt. The aim of the study is to Compare between the effectiveness of three therapeutic options for treatment of moderate and severe COPD patients .These therapeutic options include Inhaled corticosteroid (ICS)… Read more about this study

Who is it for?: Ages 30 to 70 years
Conditions the study is for: COPD
What is being tested?: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid, Tiotropium 18 mcg capsule inhaled once daily + Budesonide and Formoterol/Tiotropium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: 31 Oct 2014to 31 Dec 2019
Phase: Phase 4
Are there results?: None posted in the registry

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 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age from 30 to 40 years or older.
Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.

Who cannot join

Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
Patients with history of asthma.
Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.

About this study

Official title: Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients

Forty five COPD patients will be recruited from Chest Disease Department, Tanta University Hospital, Tanta, Egypt.

The aim of the study is to Compare between the effectiveness of three therapeutic options for treatment of moderate and severe COPD patients .These therapeutic options include Inhaled corticosteroid (ICS) plus long acting B2-agonist (LABA) combination, Inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) combination and Long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC) combination .

Read the detailed description

This study will be prospective randomized double blind study.

The forty five COPD patients will be divided into three groups:

Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).

Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).

Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).

If any worsening of dyspnea, increase of purulence, or increase of sputum production appear plus increase of peak variability more than 35% and FEV1 that necessitate a change of the regular drug medication of the patient will be recorded as exacerbation.

All patients will be submitted to the following analysis at the baseline, during and 12 weeks after the assigned treatment:

Full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mMRC or CAT test.
Forced expiratory volume in 1second (FEV1) value measurement using spirometry.
Measurement of the following inflammatory markers in serum and/ or plasma of patients under study .

Tumer necrosis factor alpha ( TNF )
Fibrinogen
Interlukin 6 ( IL6 )

Statistical analysis

The results will be statistically calculated to evaluate its clinical significance if any before ,during and after drug therapy using (ANOVA) system SPSS version 20 (2012) to compare between the three groups of patients and paired t-test will be used to compare between results before, during and after drug therapy .

Conditions: COPD
Being tested: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid, Tiotropium 18 mcg capsule inhaled once daily + Budesonide, Formoterol/Tiotropium
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.

Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bidDrug
Also called Budesonide/Formoterol
inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).
Tiotropium 18 mcg capsule inhaled once daily + BudesonideDrug
Also called Tiotropium/ Budesonide
inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).
Formoterol/TiotropiumDrug
Also called LABA /LAAC.
long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).

Study groups in NCT04520230
Study group	Role	What they receive
Group 1	Experimental	Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination (160/4.5mcg) 2 inhalations bid). Receives: Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid
Group 2	Experimental	Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg inhaled capsule once daily+ Budesonide inhalation 200 mcg twice daily). Receives: Drug: Tiotropium 18 mcg capsule inhaled once daily + Budesonide
Group 3	Experimental	Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC). (Tiotropium 18 mcg inhaled capsule once daily+ Formoterol 12 mcg inhaled capsule twice daily) Receives: Drug: Formoterol/Tiotropium

What is being measured

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

FEV1 value
Forced expiratory volume in 1second (FEV1) value
Measured: three months
Tumer necrosis factor alpha ( TNF )
serum level
Measured: three months
Interlukin 6 ( IL6 )
serum level
Measured: three months
Fibrinogen
serum level
Measured: Three months

Timeline

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

31 Oct 201431 Dec 2019

First posted20 Aug 2020
Study start31 Oct 2014
Primary completion30 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Tanta UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized double blind prospective study.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04520230
Sponsor's protocol ID: CP00011
Status last verified: Aug 2020
First submitted: 18 Aug 2020
Last updated: 20 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
PubMed 21810710
Falk JA, Minai OA, Mosenifar Z. Inhaled and systemic corticosteroids in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):506-12. doi: 10.1513/pats.200707-096ET.
PubMed 18453363
Mostafa TM, El-Azab GA, Atia GA, Lotfy NS. The Effectiveness of 3 Combined Therapeutic Regimens in Egyptian Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: A Randomized Double-Blind Prospective Pilot Study. Curr Ther Res Clin Exp. 2021 Mar 8;94:100625. doi: 10.1016/j.curtheres.2021.100625. eCollection 2021.
PubMed 34306265

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?

Official record

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study Between Three Therapeutic Options for Treatment of Chronic Obstructive Pulmonary Disease Patients
ClinicalTrials.gov ID: NCT04520230
Acronym / sponsor ID: CP00011
Conditions: COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 31 Oct 2014 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 20 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Forty five COPD patients will be recruited from Chest Disease Department, Tanta University Hospital, Tanta, Egypt.

Detailed description

This study will be prospective randomized double blind study.

The forty five COPD patients will be divided into three groups:

Group 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).

Group 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).

Group 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).

All patients will be submitted to the following analysis at the baseline, during and 12 weeks after the assigned treatment:

Full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mMRC or CAT test.
Forced expiratory volume in 1second (FEV1) value measurement using spirometry.
Measurement of the following inflammatory markers in serum and/ or plasma of patients under study .

Tumer necrosis factor alpha ( TNF )
Fibrinogen
Interlukin 6 ( IL6 )

Statistical analysis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: randomized double blind prospective study.

Arm	Type	Receives
Group 1	Experimental	Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bidGroup 1: 15 patients with COPD who will receive inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination (160/4.5mcg) 2 inhalations bid).
Group 2	Experimental	Drug: Tiotropium 18 mcg capsule inhaled once daily + BudesonideGroup 2: 15 patients with COPD who will receive inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg inhaled capsule once daily+ Budesonide inhalation 200 mcg twice daily).
Group 3	Experimental	Drug: Formoterol/TiotropiumGroup 3: 15 patients with COPD who will receive long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC). (Tiotropium 18 mcg inhaled capsule once daily+ Formoterol 12 mcg inhaled capsule twice daily)

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age from 30 to 40 years or older.
Patient with 30%≥ FEV1<80% predicted and FEV1/FVC <70% predicted.

Key exclusion criteria (4 listed)

Patients with FEV1< 30% predicted or FEV1< 50% predicted plus chronic respiratory failure.
Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
Patients with history of asthma.
Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.

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
Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bidAlso: Budesonide/Formoterolinhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).	Drug	Group 1
Tiotropium 18 mcg capsule inhaled once daily + BudesonideAlso: Tiotropium/ Budesonideinhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).	Drug	Group 2
Formoterol/TiotropiumAlso: LABA /LAAC.long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).	Drug	Group 3

Primary outcome

FEV1 value
Time frame: three months
Forced expiratory volume in 1second (FEV1) value
Tumer necrosis factor alpha ( TNF )
Time frame: three months
serum level
Interlukin 6 ( IL6 )
Time frame: three months
serum level
Fibrinogen
Time frame: Three months
serum level

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Background: PubMed 21810710Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
Background: PubMed 18453363Falk JA, Minai OA, Mosenifar Z. Inhaled and systemic corticosteroids in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):506-12. doi: 10.1513/pats.200707-096ET.
Derived from this study: PubMed 34306265Mostafa TM, El-Azab GA, Atia GA, Lotfy NS. The Effectiveness of 3 Combined Therapeutic Regimens in Egyptian Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: A Randomized Double-Blind Prospective Pilot Study. Curr Ther Res Clin Exp. 2021 Mar 8;94:100625. doi: 10.1016/j.curtheres.2021.100625. eCollection 2021.
Individual participant dataSharing planned: No

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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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.

Tarek M Mostafa, Ass. Prof. principal investigator

Tanta University

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 2 inclusion and 4 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 2020. Status can change between updates, so confirm with the study contact before making plans.

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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

FEV1 value (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520230, 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 2020.