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CompletedNCT04520230Updated Aug 20, 2020

Three Treatment of Chronic Obstructive Pulmonary Disease Patients

A Phase 4 interventional study of Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid and Tiotropium 18 mcg capsule inhaled once daily + Budesonide in COPD, sponsored by Tanta University. Completed. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-20.

Sponsored by Tanta University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Oct 2014, registered Aug 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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) 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:

  1. Full medical history will be taken through clinical assessment of dyspnea, chronic cough and sputum production using mMRC or CAT test.
  2. Forced expiratory volume in 1second (FEV1) value measurement using spirometry.

  3. 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 .

02

Conditions studied

  • COPD
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 45 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with FEV1\< 30% predicted or FEV1\< 50% predicted plus chronic respiratory failure.
  2. Patients with recent chest infection or had been hospitalised for an exacerbation or respiratory infection in the 6 weeks before screening.
  3. Patients with history of asthma.
  4. Patient with clinically significant condition ex; unstable ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Group 1

    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).

    Drug: Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid

  • Experimental
    Group 2

    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).

    Drug: Tiotropium 18 mcg capsule inhaled once daily + Budesonide

  • Experimental
    Group 3

    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)

    Drug: Formoterol/Tiotropium

Interventions

  • DrugBudesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid

    inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).

    Also known as: Budesonide/Formoterol

  • DrugTiotropium 18 mcg capsule inhaled once daily + Budesonide

    inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).

    Also known as: Tiotropium/ Budesonide

  • DrugFormoterol/Tiotropium

    long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).

    Also known as: LABA /LAAC.

06

What researchers measure

Primary outcomes

  1. FEV1 value

    Forced expiratory volume in 1second (FEV1) value

    Time frame: three months

  2. Tumer necrosis factor alpha ( TNF )

    serum level

    Time frame: three months

  3. Interlukin 6 ( IL6 )

    serum level

    Time frame: three months

  4. Fibrinogen

    serum level

    Time frame: Three months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04520230
Lead sponsor
Tanta University
Responsible party
Dr. Tarek Mohamed Mostafa (Associate Professor, Tanta University) — Principal investigator
First posted
Aug 20, 2020
Start date
Oct 31, 2014
Primary completion
Dec 30, 2019
Completion
Dec 31, 2019
Last update
Aug 20, 2020

Study contacts

Tarek M Mostafa, Ass. Prof.
principal investigator · Tanta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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