Three Treatment of Chronic Obstructive Pulmonary Disease Patients

NCT04520230 | Completed Phase 4

• 1 other identifier: CP00011
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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 .

Conditions

COPD

Outcome Measures

Primary Outcomes (4)

• FEV1 value

  Forced expiratory volume in 1second (FEV1) value

  three months

• Tumer necrosis factor alpha ( TNF )

  serum level

  three months

• Interlukin 6 ( IL6 )

  serum level

  three months

• Fibrinogen

  serum level

  Three months

Study Arms (3)

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).

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).

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)

Drug: Formoterol/Tiotropium

Interventions

Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid DRUG

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

Also known as: Budesonide/Formoterol

Group 1

Tiotropium 18 mcg capsule inhaled once daily + Budesonide DRUG

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

Also known as: Tiotropium/ Budesonide

Group 2

Formoterol/Tiotropium DRUG

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

Also known as: LABA /LAAC.

Group 3

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (3)

• 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.

  PMID: 21810710 BACKGROUND

• 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.

  PMID: 18453363 BACKGROUND

• 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.

  PMID: 34306265 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Tiotropium Bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Tarek M Mostafa, Ass. Prof.

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized double blind prospective study.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: October 31, 2014
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share